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FDA 510(k)

Li-Battery powered OTC TENS/EMS Combination Stimulator

K-Number: K201335 · 2020-10-24

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2020-10-24
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Li-Battery powered OTC TENS/EMS Combination Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-10-24 under 510(k) number K201335. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Li-Battery powered OTC TENS/EMS Combination Stimulator?

Li-Battery powered OTC TENS/EMS Combination Stimulator is a medical device that received FDA 510(k) clearance on 2020-10-24. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K201335.

When did Li-Battery powered OTC TENS/EMS Combination Stimulator receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS Combination Stimulator received FDA 510(k) clearance on 2020-10-24, under 510(k) number K201335.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA product code for Li-Battery powered OTC TENS/EMS Combination Stimulator is NUH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01581580Deep Brain Stimulation Surgery for Movement DisordersRECRUITINGNCT06619418Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back PainRECRUITING

Other records listing Everyway Medical Instruments Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4K222488Everyway Analog OTC TENSK213116Everyway Incontinence Stimulation SystemK202849Everyway Analog OTC TENS, model N103A/N302K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

View all 13 devices →

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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