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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-10 under 510(k) 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. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K232409.

When did Electromagnetic Stimulation Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Electromagnetic Stimulation Systems?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electromagnetic Stimulation Systems?

The FDA product code for Electromagnetic Stimulation Systems is NGX.

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Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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