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LSI Silver Self Adhesive, Disposable Electrodes

FDA UDI

Class II (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
LSI Silver Self Adhesive, Disposable Electrodes FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
4 X 2.25 PIN FDA UDI
Model / Reference
300-161 FDA UDI
Description
4 X 2.25 PIN FDA UDI

Identifiers

Primary DI / UDI-DI
00850958007220 FDA UDI
510(k) Number
K050469 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

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

LSI Silver Self Adhesive, Disposable Electrodes by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K050469 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI 460711f9-6fc9-4889-bdf0-18e322f71f91 36 fields · synced May 31, 2026