# K233937: OW100S

- Pathway: 510(k) (Traditional)
- Applicant: Softwave/Trt, LLC
- Decided: Jul 9, 2024 after 208 days
- Product code: PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers)
- Device class: 2
- Regulation: 21 CFR 878.4685
- 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 DEN160037 (2017). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231710: OW100S, Softwave/Trt, LLC (2023) Summary page 4.

## Indications for use
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

Source page: https://510kreport.com/device/K233937
Methodology: https://510kreport.com/methodology