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FDA 510(k)

EMOTENS

K-Number: K813569 · 1982-02-24

ApplicantElectro Medica Office
Decision Date1982-02-24
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMOTENS is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medica Office. It received FDA 510(k) clearance on 1982-02-24 under 510(k) number K813569. 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 EMOTENS?

EMOTENS is a medical device that received FDA 510(k) clearance on 1982-02-24. The listed applicant is Electro Medica Office. The 510(k) number is K813569.

When did EMOTENS receive FDA 510(k) clearance?

EMOTENS received FDA 510(k) clearance on 1982-02-24, under 510(k) number K813569.

Who is the listed applicant for EMOTENS?

The FDA 510(k) record lists Electro Medica Office as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMOTENS?

The FDA product code for EMOTENS is GZJ.

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.

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Other records listing Electro Medica Office 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.

K870972SONAFON, THERAPEUTIC MASSAGER

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

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

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