← Back to catalogue

Softwave Gold Li

FDA UDI

Class II (US FDA UDI)

by MTS Medical AG

Identity

Trade Name
Softwave Gold Li FDA UDI
Generic Name
Dermatological extracorporeal shock wave therapy system FDA UDI
Device Name
The OW100S-US 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. OW100S-US 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. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s) FDA UDI
Model / Reference
OW100S-US FDA UDI
Description
The OW100S-US 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. OW100S-US 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. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s) FDA UDI

Identifiers

Catalog Number
1000024 FDA UDI
Primary DI / UDI-DI
04260484571267 FDA UDI
510(k) Number
K233937 FDA UDI
FDA Product Code
PZL FDA UDI
GMDN Term
Dermatological extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4685 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 21 Kilogram FDA UDI
Depth — 459 Millimeter FDA UDI
Width — 400 Millimeter FDA UDI
Height — 218 Millimeter FDA UDI

Category: Dermatological extracorporeal shock wave therapy system

Softwave Gold Li by MTS Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological extracorporeal shock wave therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
MTS Medical AG

Sources (1)

  • FDA UDI b7b9fea0-21ce-4ea2-8735-e194ae9d4a6d 38 fields · synced May 30, 2026