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FDA 510(k)

Miha Bodytec II

K-Number: K221498 · 2022-10-07

ApplicantMiha Bodytec GmbH
Decision Date2022-10-07
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Miha Bodytec II is the device name listed in this FDA 510(k) record. The listed applicant is Miha Bodytec GmbH. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221498. 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 Miha Bodytec II?

Miha Bodytec II is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Miha Bodytec GmbH. The 510(k) number is K221498.

When did Miha Bodytec II receive FDA 510(k) clearance?

Miha Bodytec II received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221498.

Who is the listed applicant for Miha Bodytec II?

The FDA 510(k) record lists Miha Bodytec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Miha Bodytec II?

The FDA product code for Miha Bodytec II is NGX.

Other records listing Miha Bodytec GmbH 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.

K201975miha bodytec IIK182519Miha Bodytec II

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

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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