K232982
- 510(k) number
- K232982
- Device name
- EMS Sculpt Machine
- Applicant
- Shandong Huamei Technology Co., Ltd. CN
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2024-11-25
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K232982.pdf
Official FDA record: K232982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.