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FDA 510(k)

STIMATE N601 TENS

K-Number: K003487 · 2001-01-24

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2001-01-24
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMATE N601 TENS 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 2001-01-24 under 510(k) number K003487. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMATE N601 TENS?

STIMATE N601 TENS is a medical device that received FDA 510(k) clearance on 2001-01-24. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K003487.

When did STIMATE N601 TENS receive FDA 510(k) clearance?

STIMATE N601 TENS received FDA 510(k) clearance on 2001-01-24, under 510(k) number K003487.

Who is the listed applicant for STIMATE N601 TENS?

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 STIMATE N601 TENS?

The FDA product code for STIMATE N601 TENS is GZJ.

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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 27 devices →

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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