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FDA 510(k)

EMS Sculpt Machine

K-Number: K232982 · 2024-11-25

ApplicantShandong Huamei Technology Co., Ltd.
Decision Date2024-11-25
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS Sculpt Machine is a medical device manufactured by Shandong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-25 under approval number K232982. 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 EMS Sculpt Machine?

EMS Sculpt Machine is a medical device that received FDA 510(k) clearance on 2024-11-25. It is manufactured by Shandong Huamei Technology Co., Ltd.. The 510(k) number is K232982.

When was EMS Sculpt Machine approved by the FDA?

EMS Sculpt Machine received FDA 510(k) clearance on 2024-11-25, under approval number K232982.

What company makes EMS Sculpt Machine?

EMS Sculpt Machine is manufactured by Shandong Huamei Technology Co., Ltd..

What is the FDA product code for EMS Sculpt Machine?

The FDA product code for EMS Sculpt Machine is NGX.

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Official Source

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