K233070
- 510(k) number
- K233070
- Device name
- Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
- Applicant
- Chongqing Rob Linka Science and Technology Co., Ltd. CN
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2024-03-13
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.