Clearance Summary
Cold Compression Wrap Pro received FDA 510(k) clearance under submission number K230524, sponsored by Chengdu Cryo-Push Medical Technology Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2024-01-19.
- Submission: K230524
- Applicant / Sponsor: Chengdu Cryo-Push Medical Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2024-01-19
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.