# K141342: Wearable Therapy Garments

- Pathway: 510(k) (Traditional)
- Applicant: Axiobionics, LLC
- Decided: Nov 14, 2014 after 177 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944543 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944543: Bioflex Garments, Assorted Models, Bioflex, Inc. (1995) Summary page 4.

## Indications for 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)

Source page: https://510kreport.com/device/K141342
Methodology: https://510kreport.com/methodology