Mini TENS Therapy Device

FDA 510(k) K182871 · Shenzhen Jumper Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK182871

Submission

Device name
Mini TENS Therapy Device
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
Shenzhen, CN
Received
October 12, 2018
Decision date
August 1, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Mini TENS Therapy Device cleared by the FDA?

Mini TENS Therapy Device (K182871) received a 510(k) decision of Substantially Equivalent on August 1, 2019, 293 days after the submission was received.

What is the product code of K182871?

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