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FDA 510(k)

MYOTouch Muscle Stimulator

K-Number: K233098 · 2024-08-02

ApplicantSunmed, LLC
Decision Date2024-08-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYOTouch Muscle Stimulator is a medical device manufactured by Sunmed, LLC. It received FDA 510(k) clearance on 2024-08-02 under approval 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. It is manufactured by Sunmed, LLC. The 510(k) number is K233098.

When was MYOTouch Muscle Stimulator approved by the FDA?

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

What company makes MYOTouch Muscle Stimulator?

MYOTouch Muscle Stimulator is manufactured by Sunmed, LLC.

What is the FDA product code for MYOTouch Muscle Stimulator?

The FDA product code for MYOTouch Muscle Stimulator is IPF.

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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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