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FDA 510(k)

Muscle Stimulator Device (PZ-100)

K-Number: K250038 · 2025-05-19

Decision Date2025-05-19
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Muscle Stimulator Device (PZ-100) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) 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. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250038.

When did Muscle Stimulator Device (PZ-100) receive FDA 510(k) clearance?

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

Who is the listed applicant for Muscle Stimulator Device (PZ-100)?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Zhengzhou PZ Laser Slim Technology Co., Ltd. as applicant

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.

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.

Official Source

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