510(k) K242615

Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) by Xiamen Taotao Technology Co., Ltd. — Product Code IRP

K242615 is an FDA 510(k) premarket notification submitted by Xiamen Taotao Technology Co., Ltd. for the device "Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)". The FDA issued a decision of Substantially Equivalent on July 23, 2025. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2025
Date Received
September 3, 2024
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