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# Class 2 for Extracorporeal Shock Wave Device
- URL: https://www.fdaweb.com/class-2-for-extracorporeal-shock-wave-device/
- Published: 2018-03-07T12:00:00.000Z
- Updated: 2026-09-14T23:28:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140920

*Federal Register* notice: FDA has classified the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls). The action is in response to a 7/2016 Sanuwave, Inc. de novo classification request for its dermaPace System. The agency has codified the device classification by adding 21 CFR 878.4685\. It is identified as a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-03-07/pdf/2018-04616.pdf?ref=fdaweb.com).