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FDA 510(k)

Powered Muscle Stimulator (Model name:MagGraver F200)

K-Number: K222875 · 2023-03-09

ApplicantNanjing Vishee Medical Technology Co., Ltd.
Decision Date2023-03-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powered Muscle Stimulator (Model name:MagGraver F200) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Vishee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K222875. 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 Powered Muscle Stimulator (Model name:MagGraver F200)?

Powered Muscle Stimulator (Model name:MagGraver F200) is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Nanjing Vishee Medical Technology Co., Ltd.. The 510(k) number is K222875.

When did Powered Muscle Stimulator (Model name:MagGraver F200) receive FDA 510(k) clearance?

Powered Muscle Stimulator (Model name:MagGraver F200) received FDA 510(k) clearance on 2023-03-09, under 510(k) number K222875.

Who is the listed applicant for Powered Muscle Stimulator (Model name:MagGraver F200)?

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

What is the FDA product code for Powered Muscle Stimulator (Model name:MagGraver F200)?

The FDA product code for Powered Muscle Stimulator (Model name:MagGraver F200) is NGX.

Other records listing Nanjing Vishee Medical Technology Co., Ltd. as applicant

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.

K230767Pelvic Floor Muscle Stimulator

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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