# K250779: CS-Pro MED

- Pathway: 510(k) (Traditional)
- Applicant: Curative Sound Therapeutics
- Decided: Jul 2, 2025 after 110 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duolith SD1 with C-ACTOR: named in the summary without a submission number

## Indications for use
The CS-Pro MED is intended to provide acoustic shock waves 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 CS-Pro MED is indicated for adults (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.

Source page: https://510kreport.com/device/K250779
Methodology: https://510kreport.com/methodology