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FDA 510(k)

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)

K-Number: K232181 · 2024-04-24

ApplicantHebei JT Medical Co., Ltd.
Decision Date2024-04-24
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is a medical device manufactured by Hebei JT Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-04-24 under approval number K232181. 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 Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is a medical device that received FDA 510(k) clearance on 2024-04-24. It is manufactured by Hebei JT Medical Co., Ltd.. The 510(k) number is K232181.

When was Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) approved by the FDA?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) received FDA 510(k) clearance on 2024-04-24, under approval number K232181.

What company makes Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is manufactured by Hebei JT Medical Co., Ltd..

What is the FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)?

The FDA product code for Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) is NGX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41644679 Scaling medical device regulatory science using large language models. NPJ digital medicine (2026) PMID: 40978510 Federated learning: a privacy-preserving approach to data-centric regulatory cooperation. Frontiers in drug safety and regulation (2025) PMID: 40972375 AI-based EEG analysis: new technology and the path to clinical adoption. Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology (2025)

Other Devices by Hebei JT Medical Co., Ltd.

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Official Source

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