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FDA 510(k)

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

K-Number: K202317 · 2020-11-13

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2020-11-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 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 2020-11-13 under 510(k) number K202317. 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, model EV-804, model EV-805, & model EV-806?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202317.

When did Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 received FDA 510(k) clearance on 2020-11-13, under 510(k) number K202317.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

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, model EV-804, model EV-805, & model EV-806?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is NUH.

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-6300K201335Li-Battery powered OTC TENS/EMS Combination Stimulator

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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