# K261522: BioWave BioWraps

- Pathway: 510(k) (Special)
- Applicant: Biowave Corporation
- Decided: Jun 3, 2026 after 27 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: 5 generations back to K932299 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203158: BioWave BioWraps, Biowave Corporation (2021) Summary page 6.

## Indications for use
The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand/wrist, elbow, foot/ankle, knee, thigh/calf, cervical neck and lower back.

Source page: https://510kreport.com/device/K261522
Methodology: https://510kreport.com/methodology