Identity
- Trade Name
- Flex Plus FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrodes - Flex Plus -2.0" x 2.0" (1 pack = 4 electrodes per pack) FDA UDI
- Model / Reference
- ProM-022 FDA UDI
- Description
- Electrodes - Flex Plus -2.0" x 2.0" (1 pack = 4 electrodes per pack) FDA UDI
Identifiers
- Catalog Number
- ProM-022 FDA UDI
- Primary DI / UDI-DI
- 00185098000108 FDA UDI
- 510(k) Number
- K132998 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
Flex Plus by Pro Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132998 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Moore Medical — Moore Medical Corp.
- Moore Medical — Moore Medical Corp.
- Myocene Electrode — Myocene
- Baxter — PRO MEDICAL SUPPLIES, INC.
- Baxter — PRO MEDICAL SUPPLIES, INC.
- Baxter — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, 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 |
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Manufacturer
- Manufacturer
- Pro Medical Supplies, Inc.
Sources (1)
- FDA UDI 8b4fe8a1-939d-4030-a5d3-dcb380af3866 36 fields · synced May 31, 2026