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

FDA 510(k)

SLENDERTONE ENERVIVE, MODEL 561

K-Number: K071666 · 2008-03-12

ApplicantBio-Medical Research Corp.
Decision Date2008-03-12
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE ENERVIVE, MODEL 561 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research Corp.. It received FDA 510(k) clearance on 2008-03-12 under 510(k) number K071666. 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 SLENDERTONE ENERVIVE, MODEL 561?

SLENDERTONE ENERVIVE, MODEL 561 is a medical device that received FDA 510(k) clearance on 2008-03-12. The listed applicant is Bio-Medical Research Corp.. The 510(k) number is K071666.

When did SLENDERTONE ENERVIVE, MODEL 561 receive FDA 510(k) clearance?

SLENDERTONE ENERVIVE, MODEL 561 received FDA 510(k) clearance on 2008-03-12, under 510(k) number K071666.

Who is the listed applicant for SLENDERTONE ENERVIVE, MODEL 561?

The FDA 510(k) record lists Bio-Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLENDERTONE ENERVIVE, MODEL 561?

The FDA product code for SLENDERTONE ENERVIVE, MODEL 561 is NGX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio-Medical Research Corp. 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.

K070142SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20K840149BMR POWERSTIMK840148BMR-16 CLINIC MUSCLE STIMULATORK840147BMR-2 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑