510(k) K230524

Cold Compression Wrap Pro by Chengdu Cryo-Push Medical Technology Co.,Ltd — Product Code IRP

K230524 is an FDA 510(k) premarket notification submitted by Chengdu Cryo-Push Medical Technology Co.,Ltd for the device "Cold Compression Wrap Pro". The FDA issued a decision of Substantially Equivalent on January 19, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Chengdu Cryo-Push Medical Technology Co.,Ltd has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
February 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type