Identity
- Trade Name
- Pain Warrior FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes FDA UDI
- Model / Reference
- ECS322 FDA UDI
- Description
- TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes FDA UDI
Identifiers
- Catalog Number
- 77621 FDA UDI
- Primary DI / UDI-DI
- 00860001588316 FDA UDI
- FDA Product Code
- NUH FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.09 Kilogram FDA UDIHeight — 106 Millimeter FDA UDIWidth — 62 Millimeter FDA UDIDepth — 62 Millimeter FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Pain Warrior by International Trade Group Inc — 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
- International Trade Group Inc
Sources (1)
- FDA UDI 6d336564-07e9-4067-b544-76f94493d65b 37 fields · synced May 30, 2026