Electrical Stimulator System

FDA 510(k) K192201 · Gymmax Technology Shenzen Co., Ltd.

Substantially Equivalent

510(k) numberK192201

Submission

Device name
Electrical Stimulator System
Applicant
Gymmax Technology Shenzen Co., Ltd.
Shenzhen City, CN
Received
August 13, 2019
Decision date
June 12, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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Questions and answers

When was Electrical Stimulator System cleared by the FDA?

Electrical Stimulator System (K192201) received a 510(k) decision of Substantially Equivalent on June 12, 2020, 304 days after the submission was received.

What is the product code of K192201?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.