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# FDA Permits Marketing of Dermapace Foot Ulcer Device
- URL: https://www.fdaweb.com/fda-permits-marketing-of-dermapace-foot-ulcer-device/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:10:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140372

FDA is permitting marketing of Sanuwave’s Dermapace System, described by the agency as the first shock wave device intended to treat diabetic foot ulcers. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590784.htm?ref=fdaweb.com) says the system is intended to be used to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm that extend through the epidermis, dermis, tendon or capsule, but without bone exposure.

It is described as an extracorporeal shock wave system using pulses of energy, similar to sound waves, to mechanically stimulate the wound. It is intended for use with adults age 22 and older presenting with diabetic foot ulcers lasting more than 30 days, and should be used with standard diabetic ulcer care.

FDA says it reviewed data from two multi-center studies with a total of 336 diabetic patients receiving either usual care plus the Dermapace system or usual care plus sham shock wave therapy. Patients who had between one and seven Dermapace treatments showed an increase in wound healing at 24 weeks with a 44% wound closure rate, the agency says. Patients treated with the sham shock wave therapy had a 30% wound closure rate in the same time period.

The most common side effects were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound, and fever.

The Dermapace system was reviewed through the *de novo* premarket review pathway available for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device. FDA says this action creates as new regulatory classification that would allow future devices to go through the 510(k) process and demonstrate substantial equivalence to this predicate device.