Identity
- Trade Name
- Pro Comfort Tens Unit Pads FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens Unit The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment. FDA UDI
- Model / Reference
- SM120 FDA UDI
- Description
- 2 pairs (4 pads total) of Tens Unit Pads for use with the Pro Comfort Tens Unit The life of the electrodes varies depending on skin conditions, storage, amount of use, type of stimulation, and stimulation site. Electrode life may be extended by carefully following the instructions for use found in the manual. The expired electrodes are to be recycled and do not harm the environment. FDA UDI
Identifiers
- Catalog Number
- 7218 FDA UDI
- Primary DI / UDI-DI
- 00850632007218 FDA UDI
- FDA Product Code
- GXY FDA UDINUH FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI882.5890 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Pro Comfort Tens Unit Pads by Home Aide Diagnostics, 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
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI 46ed4c22-ea27-4902-acc2-740b6c993fa6 36 fields · synced May 31, 2026