Identity
- Trade Name
- ProMed FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- (25) 3" Round Red Silicone Electrodes (25 Pack Per Inner Bag - 2 Electrodes Per Pack) FDA UDI
- Model / Reference
- ProM-053R FDA UDI
- Description
- (25) 3" Round Red Silicone Electrodes (25 Pack Per Inner Bag - 2 Electrodes Per Pack) FDA UDI
Identifiers
- Catalog Number
- ProM-053R FDA UDI
- Primary DI / UDI-DI
- 10185098000860 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
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: Transcutaneous electrical stimulation electrode, single-use
ProMed by Pro Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, single-use.
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- Eswallow — COMPASS HEALTH BRANDS CORP. · Class II
- TMR-ELEC-20003221 2" WH Round electrode — Emsi · Class II
- Medical Science Products — SAUVRE INTERNATIONAL, LTD. · Class II
- AdvanTrode — PEPIN MANUFACTURING, INC. · Class II
- 3x5 fabric conductive pad — BioMedical Life Systems Inc. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- SuperStim Electrodes — COMPASS HEALTH BRANDS CORP. · Class II
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
- Pro Medical Supplies, Inc.
Sources (1)
- FDA UDI 059bd773-312d-4f46-a556-984483f86ea3 35 fields · synced Jun 8, 2026