K243791
- 510(k) number
- K243791
- Device name
- Air Pressure Therapy System
- Applicant
- Xiamen Weiyou Intelligent Technology Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-01-13
- Date received
- 2024-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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: K243791
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.