K250038
- 510(k) number
- K250038
- Device name
- Muscle Stimulator Device (PZ-100)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd. CN
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2025-05-19
- Date received
- 2025-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250038.pdf
Official FDA record: K250038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.