Identity
- Trade Name
- TB12 VIBRATING PLIABILITY ROLLER FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being. FDA UDI
- Model / Reference
- VPLI-RED-02A FDA UDI
- Description
- Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580657301003 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held electric massager
Tb12 Vibrating Pliability Roller by Dream Factory Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dream Factory Inc.
Sources (1)
- FDA UDI 0829c3c4-942c-4113-b1e1-cb6e447a86f5 33 fields · synced Jun 8, 2026