# K944543: Bioflex Garments, Assorted Models

- Pathway: 510(k) (Traditional)
- Applicant: Bioflex, Inc.
- Decided: Jul 19, 1995 after 307 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141342: Wearable Therapy Garments (2014), 0 descendants of its own

## Recalls of this device
- May 27, 2011 · Not classified · Z-2898-2011: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
- May 27, 2011 · Not classified · Z-2899-2011: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
- May 27, 2011 · Not classified · Z-2900-2011: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
- May 27, 2011 · Not classified · Z-2901-2011: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.

Source page: https://510kreport.com/device/K944543
Methodology: https://510kreport.com/methodology