Pocket TENS (EP-300)

FDA 510(k) K242815 · Hivox Biotek, Inc.

Substantially Equivalent

510(k) numberK242815

Submission

Device name
Pocket TENS (EP-300)
Applicant
Hivox Biotek, Inc.
New Taipei City, TW
Received
September 18, 2024
Decision date
December 17, 2024
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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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
K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional 06/16/2026SE
K232675Heating Tens, FT-615NUH · Special 10/05/2023SE
K223308Heating Tens/Ems, FT-810RNUH · Traditional 05/13/2023SE
K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2NUH · Special 06/11/2022SE
K211403HIVOX OTC Electrical Stimulator, FT610-BNUH · Traditional 10/15/2021SE
K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUH · Traditional 03/10/2021SE
K192264HIVOX Spopad EMS SP-911, SP-921NGX · Special 11/08/2019SE
K190347HIVOX OTC Electrical StimulatorNUH · Special 03/15/2019SE
K171803HIVOX OTC Electrical StimulatorNUH · Traditional 11/29/2017SE
K143737EM25 - glute toning deviceNGX · Traditional 07/27/2015SE

Questions and answers

When was Pocket TENS (EP-300) cleared by the FDA?

Pocket TENS (EP-300) (K242815) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 90 days after the submission was received.

What is the product code of K242815?

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