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)

Electromagnetic Stimulation Systems

K-Number: K232409 · 2024-04-10

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2024-04-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electromagnetic Stimulation Systems is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-10 under approval number K232409. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electromagnetic Stimulation Systems?

Electromagnetic Stimulation Systems is a medical device that received FDA 510(k) clearance on 2024-04-10. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K232409.

When was Electromagnetic Stimulation Systems approved by the FDA?

Electromagnetic Stimulation Systems received FDA 510(k) clearance on 2024-04-10, under approval number K232409.

What company makes Electromagnetic Stimulation Systems?

Electromagnetic Stimulation Systems is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for Electromagnetic Stimulation Systems?

The FDA product code for Electromagnetic Stimulation Systems is NGX.

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 NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT06898138 Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations NOT_YET_RECRUITING NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression RECRUITING NCT07580547 Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes NOT_YET_RECRUITING

Other Devices by Shanghai Apolo Medical Technology Co., Ltd.

K191349980nm Diode Laser Therapy Device K190938Phototherapy System K190936Q-Switched Nd: YAG Laser System K201731Diode Laser Body Sculpture System K201109CO2 Laser Therapy System K200116PicoSecond Nd: YAG Laser System

View all 14 devices →

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

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.

↑