Identity
- Trade Name
- ROOVJOY FDA UDI
- Generic Name
- Transcutaneous electrical stimulation probe FDA UDI
- Device Name
- It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, joint, hip,hand, abdomen, foot, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. FDA UDI
- Model / Reference
- R-C101G FDA UDI
- Description
- It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, joint, hip,hand, abdomen, foot, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840001700260 FDA UDI
- FDA Product Code
- NUH FDA UDIGZL FDA UDIIPF FDA UDINGX FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI882.1330 FDA UDI890.5850 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemTranscutaneous electrical stimulation probe
Roovjoy by Shenzhen roundwhale technology co. LTD. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen roundwhale technology co. LTD.
Sources (1)
- FDA UDI 658600c2-464e-41c7-8553-ad01b33570e7 33 fields · synced May 30, 2026