FDA 510(k)

MYOTouch Muscle Stimulator

K-Number: K233098 · 2024-08-02

Decision Date2024-08-02

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MYOTouch Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed, LLC. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K233098. 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 MYOTouch Muscle Stimulator?

MYOTouch Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Sunmed, LLC. The 510(k) number is K233098.

When did MYOTouch Muscle Stimulator receive FDA 510(k) clearance?

MYOTouch Muscle Stimulator received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233098.

Who is the listed applicant for MYOTouch Muscle Stimulator?

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

What is the FDA product code for MYOTouch Muscle Stimulator?

The FDA product code for MYOTouch Muscle Stimulator is IPF.

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.

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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.