SmartTENS

FDA 510(k) K143430 · Easy Med Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK143430

Submission

Device name
SmartTENS
Applicant
Easy Med Instrument Co., Ltd.
Daliang, Shunde, Foshan, Guang Dong, CN
Received
December 1, 2014
Decision date
May 29, 2015
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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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K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

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K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special 05/13/2016SE
K050921Easystim NMS-28IPF · Abbreviated 12/12/2005SE
K040253Easy Med TN-28 CGZJ · Traditional 04/08/2004SE

Questions and answers

When was SmartTENS cleared by the FDA?

SmartTENS (K143430) received a 510(k) decision of Substantially Equivalent on May 29, 2015, 179 days after the submission was received.

What is the product code of K143430?

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