# K192234: ActiPatch

- Pathway: 510(k) (Traditional)
- Applicant: Bioelectronics Corporation
- Decided: Jan 31, 2020 after 165 days
- Product code: PQY (Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain)
- Device class: 2
- Regulation: 21 CFR 890.5290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903675 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152432: ActiPatch (R), Bioelectronics Corporation (2017) Summary page 4.

## Indications for use
Adjunctive treatment of musculoskeletal pain

Source page: https://510kreport.com/device/K192234
Methodology: https://510kreport.com/methodology