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510(k) Data Aggregation
K Number
K141342Device Name
WEARABLE THERAPY GARMENTS
Manufacturer
Date Cleared
2014-11-14
(177 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXIOBIONICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AxioBionics® Wearable Therapy® Garments with cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin via electro conductive media gel.
Example of electrical stimulation applications of the garment are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief b) Neuromuscular Electrical Stimulation (NMES) for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion c) Functional Electrical Stimulation (FES)
Device Description
The AxioBionics Wearable Therapy Garments that are garments that are made of nylon/spandex and neoprene fabric that hold and position the system's electrodes. Channels are built into the garments to allow the wiring of the electrodes to be managed for the patient. The garments can be worn as produced or altered (tailored) as needed for user fitment. The conducting element is contained in a positionable electrode for electro-conductivity. The gel permeable electrode pocket is on the inside of the garment. The garment is re-usable and washable as is the electrode
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