Identity
- Trade Name
- D-ACTOR® FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy. FDA UDI
- Model / Reference
- 50 FDA UDI
- Description
- Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630039101121 FDA UDI
- 510(k) Number
- K173692 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
Category: Hand-held electric massagerPressure-wave skin/body contouring system
D-Actor® by Storz Medical AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure-wave skin/body contouring system.
- Slimspec — Medispec, Ltd. · Class I
- D-ACTOR® — Storz Medical AG · Class I
- MASTERPULS® — Storz Medical AG · Class I
- D-ACTOR® — Storz Medical AG · Class I
- DUOLITH® — Storz Medical AG · Class I
Cleared under the same submission
K173692 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Storz Medical AG
Sources (1)
- FDA UDI 67d24aa4-092b-4ad0-9f55-0738d93476b9 34 fields · synced Jun 8, 2026