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hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution
- 00860003469828 ()
- Otoscope, direct
No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution
- 00860003469811 ()
- Tone audiometer
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution
- 10860003469801 ()
- 00860003469804 ()
Lumen 155
- Air-conduction hearing aid, behind-the-ear
Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution
- 00860003372906 ()
- Natural conception assistance kit
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
None
In Commercial Distribution
- 00860003340608 ()
- Infusion pump medication-dosage application software
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution
- 00860003118368 ()
- Medical networking interface unit
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
Canary Medical USA LLC
43-5571-058-14
In Commercial Distribution
- 00860003118351 ()
- Knee tibia prosthesis trial, reusable
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution
- 00860003118320 ()
- Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution
- 00860003118313 ()
- Medical networking interface unit
The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit low-amplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted on a fabric belt. The vibration pack is secured tightly against the lower back with a strap that is buckled in the front and pulled tight by the patient. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. A thin piece of foam padding is attached to the belt at the interface between the patient’s clothing and the vibration pack to improve comfort and facilitate consistent vibration transfer to the patient’s spine and hips. After belt placement and before the beginning of each treatment session, the Osteoboost performs a fit check and a calibration step to ensure that a safe and therapeutic dose is delivered to the patient. The calibration step typically takes 5-20 seconds. The device is available in three sizes and each size adjusts in belt length 5-10 inches. The size range accommodates a hip circumference from 32 to 56 inches. The device is intended to be worn and used to administer treatment during normal daily activities that involve an upright patient body position. Specifically, administer treatment during activities that involve standing and walking, such as getting ready in the morning, cooking, doing the dishes, other light household chores, going for a walk, and walking the dog.
Bone Health Technologies, Inc
Large
Not in Commercial Distribution
- 00860003039748 ()
FGN-09-3004
- Circulatory/musculoskeletal vibration therapy unit, hand-held