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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 the device name listed in this FDA 510(k) record. The listed applicant is Medical Currents, Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) 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. The listed applicant is Medical Currents, Ltd.. The 510(k) number is K182794.

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

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

Who is the listed applicant for BionicGym Powered Muscle Stimulator?

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

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

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

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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