General & Plastic Surgery › SurgicalExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

dermaPACE System (Console With Applicator)

Name: dermaPACE System (Console with applicator)
Brand: dermaPACE System (Console with applicator)

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to…

Registry build 21.09.26

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

6manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Hebei (3), Beijing (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PZL
Manufacturer	City	Province	Registered as	Device types
E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	2
Beijing Spiritlaser Science & Technology Co., Ltd.	Beijing	Beijing	Contract manufacturer	21
Hebei Tuosite Technology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	14
Beijing Perfectlaser Technology Co., Ltd.	Beijing	Beijing	Manufacturer	12
Hebei Lufen Tech Co., Limited	Xingtai	Hebei	Contract manufacturer	12
Sanhe Jumei Technology Co., Ltd.	Sanhe	Hebei	Manufacturer	12

Record

Regulatory record for dermaPACE System (Console with applicator)
Listed by	Sanuwave, Inc., United States
FDA product code	PZL
Device type	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device class	Class 2
Regulation	21 CFR 878.4685
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2021-01-25
Record revised	2025-09-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for dermaPACE System (Console with applicator)
Catalogue number	Size	Status
DEP0330/DAP0332		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dermagold100	MTS Medical AG	2
dermaPACE Applicator	Sanuwave, Inc.	1
CS-Pro MED	Curative Sound, LLC	1
dermaPACE Console	Sanuwave, Inc.	1
Softwave Gold Li	MTS Medical AG	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
DEN160037	2017-12-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.