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Grafco

FDA UDI

Class II (US FDA UDI)

by GF Health Products, Inc

Identity

Trade Name
Grafco FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
TENS Unit, Analog FDA UDI
Model / Reference
GF-3 FDA UDI
Description
TENS Unit, Analog FDA UDI

Identifiers

Primary DI / UDI-DI
M368GF31 FDA UDI
510(k) Number
K002874 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Grafco by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K002874 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GF Health Products, Inc

Sources (1)

  • FDA UDI 84d437d6-0e3a-4b87-8e42-2edee06a66e0 36 fields · synced Jun 8, 2026