Muscle Stimulator Device (PZ-100)
FDA 510(k) K250038 · Zhengzhou PZ Laser Slim Technology Co., Ltd.
Submission
- Device name
- Muscle Stimulator Device (PZ-100)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
Zhengzhou City, CN - Received
- January 8, 2025
- Decision date
- May 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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Questions and answers
When was Muscle Stimulator Device (PZ-100) cleared by the FDA?
Muscle Stimulator Device (PZ-100) (K250038) received a 510(k) decision of Substantially Equivalent on May 19, 2025, 131 days after the submission was received.
What is the product code of K250038?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.