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)

Electrical Neuromuscular Stimulator, Cure Trio

K-Number: K233046 · 2024-04-19

ApplicantOriental Inspiration Limited
Decision Date2024-04-19
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electrical Neuromuscular Stimulator, Cure Trio is a medical device manufactured by Oriental Inspiration Limited. It received FDA 510(k) clearance on 2024-04-19 under approval number K233046. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrical Neuromuscular Stimulator, Cure Trio?

Electrical Neuromuscular Stimulator, Cure Trio is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Oriental Inspiration Limited. The 510(k) number is K233046.

When was Electrical Neuromuscular Stimulator, Cure Trio approved by the FDA?

Electrical Neuromuscular Stimulator, Cure Trio received FDA 510(k) clearance on 2024-04-19, under approval number K233046.

What company makes Electrical Neuromuscular Stimulator, Cure Trio?

Electrical Neuromuscular Stimulator, Cure Trio is manufactured by Oriental Inspiration Limited.

What is the FDA product code for Electrical Neuromuscular Stimulator, Cure Trio?

The FDA product code for Electrical Neuromuscular Stimulator, Cure Trio is GZJ.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED 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 NCT07606222 Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection COMPLETED NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING NCT04957355 Effect of NMES on Balance and Fall Risk in Chronic Stroke RECRUITING

Other Devices by Oriental Inspiration Limited

K170269Hee HR Mini K170260BC-001+ Acne Purifier K212285Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) K213133Keffort (MC-100, MC-100A)

Related Devices (Code: GZJ)

K160246SimulCare II(TM)Xanacare Technologies, LLC K153704StriveDjo, LLC K152676FD TENS 2090, FD TENS 2095Fuji Dynamics , Ltd. K173233ReliefBand 1.5Reliefband Technologies K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605AWell-Life Healthcare 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.

↑