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)

Biofeedback Nerve and Muscle Stimulator

K-Number: K202648 · 2020-12-08

ApplicantShenzhen Konmed Technology Co., Ltd.
Decision Date2020-12-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Biofeedback Nerve and Muscle Stimulator is a medical device manufactured by Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-08 under approval number K202648. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biofeedback Nerve and Muscle Stimulator?

Biofeedback Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-12-08. It is manufactured by Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K202648.

When was Biofeedback Nerve and Muscle Stimulator approved by the FDA?

Biofeedback Nerve and Muscle Stimulator received FDA 510(k) clearance on 2020-12-08, under approval number K202648.

What company makes Biofeedback Nerve and Muscle Stimulator?

Biofeedback Nerve and Muscle Stimulator is manufactured by Shenzhen Konmed Technology Co., Ltd..

What is the FDA product code for Biofeedback Nerve and Muscle Stimulator?

The FDA product code for Biofeedback Nerve and Muscle Stimulator is IPF.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING NCT01581580 Deep Brain Stimulation Surgery for Movement Disorders RECRUITING

Other Devices by Shenzhen Konmed Technology Co., Ltd.

K163288Pelvifine Pelvic Muscle Trainer K171722Electrodes with snap / Electrodes with pigtail K171721Electrodes with silver conductive K220161Biofeedback Nerve and Muscle Stimulator K233576Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)

Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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.

↑