Li-Battery powered OTC TENS/EMS Combination Stimulator

FDA 510(k) K201335 · Everyway Medical Instruments Co.,Ltd

Substantially Equivalent

510(k) numberK201335

Submission

Device name
Li-Battery powered OTC TENS/EMS Combination Stimulator
Applicant
Everyway Medical Instruments Co.,Ltd
Shenkeng District, New Taipei City, TW
Received
May 20, 2020
Decision date
October 24, 2020
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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K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/26/2026SE
K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional Hivox Biotek, Inc.06/16/2026SE
K253896TENS/EMS device (GUSE01)NUH · Traditional Globalcare Medical Technology Co., Ltd.03/04/2026SE
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
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

510(k)DeviceDecision
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special 11/21/2025SE
K222488Everyway Analog OTC TENSNUH · Traditional 11/15/2022SE
K213116Everyway Incontinence Stimulation SystemKPI · Traditional 12/03/2021SE
K202849Everyway Analog OTC TENS, model N103A/N302NUH · Traditional 12/22/2020SE
K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUH · Traditional 11/25/2020SE
K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUH · Traditional 11/13/2020SE
K192589Everyway OTC TENS/EMS CombinationNUH · Traditional 12/19/2019SE
K182767V2 OTC Pain Relief TENSNUH · Special 10/26/2018SE
K182753A6 OTC Pain Relief TENSNUH · Special 10/26/2018SE
K181707Everyway Wireless TENS & EMS UnitNUH · Traditional 09/26/2018SE

Questions and answers

When was Li-Battery powered OTC TENS/EMS Combination Stimulator cleared by the FDA?

Li-Battery powered OTC TENS/EMS Combination Stimulator (K201335) received a 510(k) decision of Substantially Equivalent on October 24, 2020, 157 days after the submission was received.

What is the product code of K201335?

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