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 shoulder, low back, joint, hip,upper extremities (arm) and lower extremities (leg) due to 6 strain from exercise or normal household work activities. FDA UDI
- Model / Reference
- R-C4D FDA UDI
- Description
- It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip,upper extremities (arm) and lower extremities (leg) due to 6 strain from exercise or normal household work activities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840001700116 FDA UDI
- FDA Product Code
- GZJ FDA UDIIPF FDA UDINGX FDA UDINUH FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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 f5b341f6-0f76-49ca-bca6-99bef672ee28 33 fields · synced May 30, 2026