Identity
- Trade Name
- TrueStim FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Wired Classic Stimulation System WHITE FDA UDI
- Model / Reference
- JQ-5C-J FDA UDI
- Description
- Wired Classic Stimulation System WHITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851640007122 FDA UDI
- 510(k) Number
- K102598 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation leadTranscutaneous electrical stimulation electrode, reusable
TrueStim 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
K102598 also covers:
- PainAway Pro — Drive Devilbiss Healthcare
- PainAway Pro — Drive Devilbiss Healthcare
- ECHO — HI-DOW INTERNATIONAL INC.
- Hi-Dow — HI-DOW INTERNATIONAL INC.
- HiDow — HI-DOW INTERNATIONAL INC.
- HiDow — HI-DOW INTERNATIONAL INC.
- HiDow — HI-DOW INTERNATIONAL INC.
- HiDow — HI-DOW INTERNATIONAL INC.
- HiDow — HI-DOW INTERNATIONAL INC.
- HiDow, SuperTens — HI-DOW INTERNATIONAL INC.
- TrueStim — HI-DOW INTERNATIONAL INC.
- COPPER Fit — Hi-Dow International Incorporated
Authorization Coverage (1 country)
Regulatory Authorizations
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 f3bcae4b-0c29-4d01-821e-865ffddf7c7a 34 fields · synced May 30, 2026