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FDA 510(k)

BionicGym Powered Muscle Stimulator

K-Number: K182794 · 2019-07-18

ApplicantMedical Currents, Ltd.
Decision Date2019-07-18
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BionicGym Powered Muscle Stimulator is a medical device manufactured by Medical Currents, Ltd.. It received FDA 510(k) clearance on 2019-07-18 under approval number K182794. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BionicGym Powered Muscle Stimulator?

BionicGym Powered Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Medical Currents, Ltd.. The 510(k) number is K182794.

When was BionicGym Powered Muscle Stimulator approved by the FDA?

BionicGym Powered Muscle Stimulator received FDA 510(k) clearance on 2019-07-18, under approval number K182794.

What company makes BionicGym Powered Muscle Stimulator?

BionicGym Powered Muscle Stimulator is manufactured by Medical Currents, Ltd..

What is the FDA product code for BionicGym Powered Muscle Stimulator?

The FDA product code for BionicGym Powered Muscle Stimulator is NGX.

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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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