Identity
- Trade Name
- PainAway Pro FDA UDI
- Generic Name
- Transcutaneous electrical stimulation lead FDA UDI
- Device Name
- Receiver for RTLAGF-900 FDA UDI
- Model / Reference
- RTLAGF-910 FDA UDI
- Description
- Receiver for RTLAGF-900 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383549408 FDA UDI
- 510(k) Number
- K102598 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation lead 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-usePhysical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation lead
PainAway Pro by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation lead.
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- Avazzia — Avazzia, Inc. · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
- C.M.P. Cable — C.M.P. Canadian Medical Products Inc · Class II
Cleared under the same submission
K102598 also covers:
- 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
- ECHO — 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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 4d4a866a-a66e-460f-8d48-539273c7f36b 34 fields · synced Jun 8, 2026