Identity
- Trade Name
- Pro Advantage FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Pro Advantage Unit Tens Digital FDA UDI
- Model / Reference
- P642000 FDA UDI
- Description
- Pro Advantage Unit Tens Digital FDA UDI
Identifiers
- Catalog Number
- P642000 FDA UDI
- Primary DI / UDI-DI
- M220P6420002 FDA UDI
- 510(k) Number
- K073438 FDA UDI
- FDA Product Code
- GZJ 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Pro Advantage by National Distribution & Contracting, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073438 also covers:
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Impulse 4000T — BioMedical Life Systems Inc.
- Therapist’s Choice® TENS 3MT — CLINICAL HEALTH SERVICES, INC.
- DeRoyal — DEROYAL INDUSTRIES, INC.
- MediMax Tech — MEDIMAX TECH INC.
- MediMax Tech — MEDIMAX TECH INC.
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
- National Distribution & Contracting, Inc.
Sources (1)
- FDA UDI 846e3f5a-817f-4902-8ee1-6fa9106e139f 36 fields · synced May 30, 2026