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FDA 510(k)

POWERED MUSCLE STIMULATOR

K-Number: K112148 · 2012-04-30

ApplicantValmed, SA
Decision Date2012-04-30
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWERED MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Valmed, SA. It received FDA 510(k) clearance on 2012-04-30 under 510(k) number K112148. 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 POWERED MUSCLE STIMULATOR?

POWERED MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 2012-04-30. The listed applicant is Valmed, SA. The 510(k) number is K112148.

When did POWERED MUSCLE STIMULATOR receive FDA 510(k) clearance?

POWERED MUSCLE STIMULATOR received FDA 510(k) clearance on 2012-04-30, under 510(k) number K112148.

Who is the listed applicant for POWERED MUSCLE STIMULATOR?

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

What is the FDA product code for POWERED MUSCLE STIMULATOR?

The FDA product code for POWERED MUSCLE STIMULATOR 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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Related PubMed Literature

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.

PMID: 30799667Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.The Journal of dermatological treatment ()

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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