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The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.
It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.
The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.
Stimulator, Electrical, Non-implantable, for Incontinence –
Title 21, Code of Federal Regulations Sec.876.5320
ProCode: KPI
Regulation Number: 21 CFR 876.5320
Regulatory Class: II
TENSCARE LIMITED
Kegel Fit 2
In Commercial Distribution
- 05033435134403 ()
K-KEGEL2
- Perineal orifice incontinence-control electrical stimulation system, home-use
The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.
It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.
The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.
Stimulator, Electrical, Non-implantable, for Incontinence –
Title 21, Code of Federal Regulations Sec.876.5320
ProCode: KPI
Regulation Number: 21 CFR 876.5320
Regulatory Class: II
TENSCARE LIMITED
KegelFit2
In Commercial Distribution
- 05033435132089 ()
K-KEGEL
- Perineal orifice incontinence-control electrical stimulation system
Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures.
Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.
Surgical Procedure Packs may be packages as a combination of any of the following components:
- Surgical gowns (various models) with or without hand towels
- Surgical Drapes:
- Mayo drape
- Absorbent/liquid proof drapes (with or without adhesive)
- Adhesive side drape
- Liquid repellent drape with or without adhesive
- Face mask
- Protective caps
- Sheath/tubing sleeve
- Surgical aspirator with adaptor
- Surgical gauze
- Disinfection sponge and/or basin
- Adhesive films
- Syringe
- Needles
- Single-use scalpel
- Small dental mirror/dental explorer/tweezer
- Irrigation/infusion line
- Stopcock and ramp for infusion
- Waste bag for contaminated material
- Bone collector
- Saliva ejector
- Basin
- Medical paper
Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI"
Model Number:
X = alphabetic character
YYYY= n° of 4 number character
OMNIA SRL
12.XYYYY.00
In Commercial Distribution
- 8056646500239 ()
- 08056646500222 ()
- 8056646500246 ()
- 8056646500352 ()
- 8056646500253 ()
- 8056646500260 ()
- 8056646500277 ()
- 8056646500284 ()
- 8056646500291 ()
- 8056646500307 ()
- 8056646500314 ()
- 8056646500321 ()
- 8056646500338 ()
- 8056646500345 ()
- 8056646500437 ()
- 8056646500420 ()
- 8056646500413 ()
- 8056646500406 ()
- 8056646500390 ()
- 8056646500383 ()
- 8056646500376 ()
- 8056646500369 ()
- 8056646500451 ()
- 8056646500444 ()
- 8056646500475 ()
- 8056646500468 ()
- 80566465000505 ()
- 805664650505 ()
- 8056646500505 ()
- 8056646500512 ()
- 08056646500529 ()
- 08056646500536 ()
- 08056646500543 ()
- 08056646500550 ()
- 08056646500567 ()
- 08056646500581 ()
- 08056646500635 ()
- 08056646500628 ()
- 08056646500611 ()
- 08056646500574 ()
- 08056646500604 ()
- 08056646500598 ()
- 08056646500659 ()
- 08056646500666 ()
- 08056646500642 ()
- 08056646500673 ()
- 08056646500680 ()
- 08056646500697 ()
- 08056646500826 ()
- 08056646500819 ()
- 08056646500802 ()
- 08056646500796 ()
- 08056646500789 ()
- 08056646500772 ()
- 08056646500765 ()
- 08056646500758 ()
- 08056646500734 ()
- 08056646500727 ()
- 08056646500710 ()
- 08056646500703 ()
- General surgical procedure kit, non-medicated, single-use
CoverScanMD is a standalone, post-processing software as a medical device (SaMD) specifically designed for the processing and analysis of magnetic resonance imaging (MRI) data. It enables the visualisation, analysis and generation of quantitative metrics and composite images from MRI scans.
CoverScanMD consists of MultiScan software and a data consolidation software which reads results from compatible SaMD's that are independently authorised for use as medical devices. The data consolidation software compiles all the input data (metrics and image references) and produces a single JSON file output which are then used to generate quantitative multi-parametric MRI reports. The data consolidation software does not modify any input data, instead, it just appends all data into one single JSON file and a list of associated images for report generation. The report generation is done outside the CoverScanMD medical device and hence does not form part of the CoverScanMD medical device.
When a referring healthcare professional requests quantitative analysis using CoverScanMD, relevant images are acquired from patients using a single MRI scan at the MR clinic and are transferred to the Perspectum Portal through established secure gateways. Perspectum trained operators use the CoverScanMD software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use.
CoverScanMD is only used within Perspectum’s secure infrastructure by trained operators to process clinical images and generate metrics. The metrics and composite images output by CoverScanMD are then sent to trained Healthcare Professionals who then interpret the information to make informed decisions.
PERSPECTUM LTD
1.2.0
In Commercial Distribution
- B554CSMD1200 ()
- Radiology DICOM image processing application software
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.
Page 2 of 13
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.
The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900580 ()
SPC15-90058
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.
Page 2 of 13
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.
The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900571 ()
SPC15-90057
- Home seizure monitoring system
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.
Page 2 of 13
The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician.
The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.
The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver.
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
- B481SPC15900570 ()
SPC15-90057
- Home seizure monitoring system