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FDA 510(k)

ELECTROC-GYM

K-Number: K813181 · 1982-02-19

ApplicantElectrola
Decision Date1982-02-19
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTROC-GYM is the device name listed in this FDA 510(k) record. The listed applicant is Electrola. It received FDA 510(k) clearance on 1982-02-19 under 510(k) number K813181. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROC-GYM?

ELECTROC-GYM is a medical device that received FDA 510(k) clearance on 1982-02-19. The listed applicant is Electrola. The 510(k) number is K813181.

When did ELECTROC-GYM receive FDA 510(k) clearance?

ELECTROC-GYM received FDA 510(k) clearance on 1982-02-19, under 510(k) number K813181.

Who is the listed applicant for ELECTROC-GYM?

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

What is the FDA product code for ELECTROC-GYM?

The FDA product code for ELECTROC-GYM is IPF.

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 Electrola 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.

K811250ELECTRONIC MUSCLE STIMULATORK810843EPILATRON

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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