# DEN160037: dermaPACE System

- Pathway: De Novo (Direct)
- Applicant: Sanuwave, Inc.
- Decided: Dec 28, 2017 after 521 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191961: OrthoGold (2019), 5 descendants of its own
- K200926: OrthoGold 100 (2020), 2 descendants of its own
- K231710: OW100S (2023), 1 descendant of its own
- K202112: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (2021), 1 descendant of its own
- K243279: DOLORCLAST Focused Shock Waves (2025), 0 descendants of its own

## Indications for use
The SANUWAVE dermaPACE System 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 dermaPACE System 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.

Source page: https://510kreport.com/device/DEN160037
Methodology: https://510kreport.com/methodology