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No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution
- B598GMMHT0001 ()
- B598GMMHT0002 ()
- B598GMTRK0001 ()
- Penile vacuum device
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution
- B595L2050R0 ()
- B595L2050R1 ()
- B595L2050R2 ()
L2050R
- Pulse oximeter probe, reusable
- Pulse Co-oximeter probe, reusable
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution
- B327NSS2032 ()
- B327NSS203 ()
- B327NSS2031 ()
01-1020
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution
- B327NSS202 ()
- B327NSS2022 ()
- B327NSS2021 ()
01-1011-NSS/MFS
- Acupuncture electrical stimulation system
The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution
- B327NSS201 ()
- B327NSS2012 ()
- B327NSS2011 ()
01-1021
- Acupuncture electrical stimulation system
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular
therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Bridge
In Commercial Distribution
- B327NSS200 ()
- B327NSS2002 ()
- B327NSS2001 ()
01-1017-NSS-2/Bridge
- Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
No Description
LED TECHNOLOGIES INC
RVGLOAC
In Commercial Distribution
- B347RVGLOAC1 ()
- B347RVGLOAC0 ()
- B347RVGLOAC2 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FLJOINT
In Commercial Distribution
- B347FLJOINT1 ()
- B347FLJOINT0 ()
- B347FLJOINT2 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA570610
In Commercial Distribution
- B347BA5706101 ()
- B347BA5706100 ()
- B347BA5706102 ()
- Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution
- B347BA5688101 ()
- B347BA5688100 ()
- B347BA5688102 ()
- Blue/red/infrared phototherapy lamp