# K152432: ActiPatch (R)

- Pathway: 510(k) (Traditional)
- Applicant: Bioelectronics Corporation
- Decided: Feb 3, 2017 after 526 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: 3 generations back to K903675 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022404: Actiband, Paw, LLC (2002) Summary page 4.
- K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II, Ivivi Technologies, Inc. (2008) Summary page 4.
- K092044: Orthocor Knee System, Median, Large, X-Large, Orthocor Medical (2009) Summary page 4.

## Most influential descendants
- K192234: ActiPatch (2020), 0 descendants of its own

## Indications for use
Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee

Source page: https://510kreport.com/device/K152432
Methodology: https://510kreport.com/methodology