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FDA 510(k)

Muscle Stimulator Device (PZ-100)

K-Number: K250038 · 2025-05-19

ApplicantZhengzhou PZ Laser Slim Technology Co., Ltd.
Decision Date2025-05-19
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Muscle Stimulator Device (PZ-100) is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under approval number K250038. 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 Muscle Stimulator Device (PZ-100)?

Muscle Stimulator Device (PZ-100) is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250038.

When was Muscle Stimulator Device (PZ-100) approved by the FDA?

Muscle Stimulator Device (PZ-100) received FDA 510(k) clearance on 2025-05-19, under approval number K250038.

What company makes Muscle Stimulator Device (PZ-100)?

Muscle Stimulator Device (PZ-100) is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd..

What is the FDA product code for Muscle Stimulator Device (PZ-100)?

The FDA product code for Muscle Stimulator Device (PZ-100) is NGX.

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Other Devices by Zhengzhou PZ Laser Slim Technology Co., Ltd.

K180353Diode laser hair removal device K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) K250782Fractional CO2 Laser Machine K250041Medical Picosecond ND: YAG Laser System (PZ-6)

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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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