Identity
- Trade Name
- Hi-Dow Pro-Tech FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Wireless Receiver FDA UDI
- Model / Reference
- HD-5N-N-Receiver FDA UDI
- Description
- Wireless Receiver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851640007467 FDA UDI
- 510(k) Number
- K163393 FDA UDI
- FDA Product Code
- NUH FDA UDINGX 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 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation system
Hi-Dow Pro-Tech by Hi-Dow International Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163393 also covers:
- Hi-Dow — HI-DOW INTERNATIONAL INC.
- MYOPUX — HI-DOW INTERNATIONAL INC.
- TrueStim — HI-DOW INTERNATIONAL INC.
- HiDow — Hi-Dow International Incorporated
- HiDow TrueStim — Hi-Dow International Incorporated
- MYOPUX — Hi-Dow International Incorporated
- MYOPUX — Hi-Dow International Incorporated
- PRO-TECH — Hi-Dow International Incorporated
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hi-Dow International Incorporated
Sources (1)
- FDA UDI beafc660-7b97-4e59-98b7-8c61075039e1 34 fields · synced May 30, 2026