Identity
- Trade Name
- WiTouch Pro FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis. FDA UDI
- Model / Reference
- 11.1500 FDA UDI
- Description
- WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis. FDA UDI
Identifiers
- Catalog Number
- 11.1500 FDA UDI
- Primary DI / UDI-DI
- 00853096004021 FDA UDI
- 510(k) Number
- K171599 FDA UDI
- FDA Product Code
- NUH FDA UDINYN FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 18 Millimeter FDA UDIHeight — 90 Millimeter FDA UDIWidth — 191 Millimeter FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
WiTouch Pro by Hollywog, LLC — 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
- Hollywog, LLC
Sources (1)
- FDA UDI 58de1340-d853-4539-a4c9-cdaecd72c155 38 fields · synced Jun 8, 2026