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FDA 510(k)

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

K-Number: K212285 · 2021-12-22

ApplicantOriental Inspiration Limited
Decision Date2021-12-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) is a medical device manufactured by Oriental Inspiration Limited. It received FDA 510(k) clearance on 2021-12-22 under approval number K212285. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)?

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Oriental Inspiration Limited. The 510(k) number is K212285.

When was Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) approved by the FDA?

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) received FDA 510(k) clearance on 2021-12-22, under approval number K212285.

What company makes Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)?

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) is manufactured by Oriental Inspiration Limited.

What is the FDA product code for Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)?

The FDA product code for Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) is NUH.

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 K213133Keffort (MC-100, MC-100A) K233046Electrical Neuromuscular Stimulator, Cure Trio

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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.

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