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)

Electrode Handpieces (VCT, RFTV, BMDT series)

K-Number: K232763 · 2023-10-04

ApplicantRF Medical Co., Ltd.
Decision Date2023-10-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrode Handpieces (VCT, RFTV, BMDT series) is a medical device manufactured by RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-10-04 under approval number K232763. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrode Handpieces (VCT, RFTV, BMDT series)?

Electrode Handpieces (VCT, RFTV, BMDT series) is a medical device that received FDA 510(k) clearance on 2023-10-04. It is manufactured by RF Medical Co., Ltd.. The 510(k) number is K232763.

When was Electrode Handpieces (VCT, RFTV, BMDT series) approved by the FDA?

Electrode Handpieces (VCT, RFTV, BMDT series) received FDA 510(k) clearance on 2023-10-04, under approval number K232763.

What company makes Electrode Handpieces (VCT, RFTV, BMDT series)?

Electrode Handpieces (VCT, RFTV, BMDT series) is manufactured by RF Medical Co., Ltd..

What is the FDA product code for Electrode Handpieces (VCT, RFTV, BMDT series)?

The FDA product code for Electrode Handpieces (VCT, RFTV, BMDT series) is GEI.

Related Clinical Trials

NCT06303869 Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT07556692 A Study of Home-use Brain Stimulation to Treat Bipolar Depression RECRUITING

Other Devices by RF Medical Co., Ltd.

K180999Mygen V-1000 RF System K193355Electrodes Handpieces for Mygen V-1000 RF System K221277Mygen M-3004 RF Generator M-3004

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑