EMS/TENS Massager Device

FDA 510(k) K233040 · Shenzhen Imdk Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK233040

Submission

Device name
EMS/TENS Massager Device
Applicant
Shenzhen Imdk Medical Technology Co., Ltd.
Shenzhen, CN
Received
September 25, 2023
Decision date
February 12, 2024
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 EMS/TENS Massager Device cleared by the FDA?

EMS/TENS Massager Device (K233040) received a 510(k) decision of Substantially Equivalent on February 12, 2024, 140 days after the submission was received.

What is the product code of K233040?

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