Identity
- Trade Name
- ChiroGold FDA UDI
- Generic Name
- Freestanding electric massager FDA UDI
- Device Name
- The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue. FDA UDI
- Model / Reference
- OW100S-US FDA UDI
- Description
- The ChiroGold device is intended to be used for- Relief of minor muscle aches and pain - Temporary increase in local blood circulation - Activation of connective tissue. FDA UDI
Identifiers
- Catalog Number
- 1000029 FDA UDI
- Primary DI / UDI-DI
- 04260484571281 FDA UDI
- 510(k) Number
- K213120 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Freestanding 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
Dimensions & Sizes
- Size
- Weight — 21 Kilogram FDA UDIDepth — 459 Millimeter FDA UDIWidth — 400 Millimeter FDA UDIHeight — 218 Millimeter FDA UDI
Category: Freestanding electric massager
ChiroGold by MTS Medical AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213120 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
- MTS Medical AG
Sources (1)
- FDA UDI 846e42fb-f72f-4e03-91bd-d2420d18f5fd 38 fields · synced May 30, 2026