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)

Nerve and Muscle Stimulator

K-Number: K193275 · 2020-04-11

ApplicantShenzhen Xft Medical Limited
Decision Date2020-04-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Nerve and Muscle Stimulator is a medical device manufactured by Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2020-04-11 under approval number K193275. 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 Nerve and Muscle Stimulator?

Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-04-11. It is manufactured by Shenzhen Xft Medical Limited. The 510(k) number is K193275.

When was Nerve and Muscle Stimulator approved by the FDA?

Nerve and Muscle Stimulator received FDA 510(k) clearance on 2020-04-11, under approval number K193275.

What company makes Nerve and Muscle Stimulator?

Nerve and Muscle Stimulator is manufactured by Shenzhen Xft Medical Limited.

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

The FDA product code for 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 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 NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Other Devices by Shenzhen Xft Medical Limited

K162718Foot Drop System (Model XFT-2001D) K193276Nerve and Muscle Stimulator K211094Nerve and Muscle Stimulator

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.

↑