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Pro-Med

FDA UDI

Class II (US FDA UDI)

by Pro Medical Supplies, Inc.

Identity

Trade Name
Pro-Med FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
4" Round Silicone Electrodes (1 pack = 2 electrodes per pack) FDA UDI
Model / Reference
ProM-054R FDA UDI
Description
4" Round Silicone Electrodes (1 pack = 2 electrodes per pack) FDA UDI

Identifiers

Catalog Number
ProM-054R FDA UDI
Primary DI / UDI-DI
00185098000924 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
Not 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Pro-Med by Pro Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K132998 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro Medical Supplies, Inc.

Sources (1)

  • FDA UDI 2a2ab9e1-f381-4fbb-a8c3-c8fc409a580c 37 fields · synced May 30, 2026