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E-Stim III

FDA UDI

Class II (US FDA UDI)

by Tens Plus Industrial Company

Identity

Trade Name
E-Stim III FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
The E-Stim III® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions. FDA UDI
Model / Reference
ED3981 FDA UDI
Description
The E-Stim III® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions. FDA UDI

Identifiers

Catalog Number
ED3981 FDA UDI
Primary DI / UDI-DI
14897076723536 FDA UDI
510(k) Number
K050435 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

E-Stim III by Tens Plus Industrial Company — 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

K050435 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tens Plus Industrial Company

Sources (1)

  • FDA UDI bf1fd6df-f5d5-4ef0-b8d2-63df4c4eeed1 35 fields · synced May 31, 2026