Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Bemer Int AG. It received FDA 510(k) clearance on 2021-02-04 under approval 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. It is manufactured by Bemer Int AG. The 510(k) number is K210174.

When was BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set approved by the FDA?

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

What company makes BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set?

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set is manufactured by Bemer Int AG.

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.

Related Clinical Trials

NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT06497309 Advanced Technology-based Rehabilitation Post-stroke Gait Re-learning COMPLETED NCT07207356 Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy RECRUITING NCT05695131 Clinical Feasibility & Validation of the Virtual Reality GlenxRose Speech-Language Therapies RECRUITING

Related PubMed Literature

PMID: 35582708 Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries. Regenerative therapy (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021)

Other Devices by Bemer Int AG

K151834BEMER Classic Set, BEMER Pro-Set K223919B.Light Clear Evo and B.Light Restore Evo K231368Bemer Therapy System Evo

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

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.

↑