Wireless Pain Relieve Device

FDA 510(k) K180331 · Shenzhen Dongdixin Technology Co., Ltd.

Substantially Equivalent

510(k) numberK180331

Submission

Device name
Wireless Pain Relieve Device
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN
Received
February 6, 2018
Decision date
June 22, 2018
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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K171430Incontinence Treatment Device, Model LT2061KPI · Traditional 03/15/2018SE
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K162479Smart Pain Reliever, Model LT5019NUH · Traditional 02/08/2017SE
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Questions and answers

When was Wireless Pain Relieve Device cleared by the FDA?

Wireless Pain Relieve Device (K180331) received a 510(k) decision of Substantially Equivalent on June 22, 2018, 136 days after the submission was received.

What is the product code of K180331?

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