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FDA 510(k)

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set

K-Number: K210174 · 2021-02-04

ApplicantBemer Int AG
Decision Date2021-02-04
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2021-02-04 under 510(k) number K210174. 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 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is a medical device that received FDA 510(k) clearance on 2021-02-04. The listed applicant is Bemer Int AG. The 510(k) number is K210174.

When did BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set receive FDA 510(k) clearance?

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set received FDA 510(k) clearance on 2021-02-04, under 510(k) number K210174.

Who is the listed applicant for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

The FDA 510(k) record lists Bemer Int AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

The FDA product code for BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is NGX.

Other records listing Bemer Int AG 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.

K223919B.Light Clear Evo and B.Light Restore EvoK231368Bemer Therapy System EvoK151834BEMER Classic Set, BEMER Pro-Set

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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