510(k) K262812

Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9) by Sichuan Qianli-Beoka Medical Technology, Inc. — Product Code IRP

K262812 is an FDA 510(k) premarket notification submitted by Sichuan Qianli-Beoka Medical Technology, Inc. for the device "Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)". The FDA issued a decision of Substantially Equivalent on Oct 5, 2026. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Sichuan Qianli-Beoka Medical Technology, Inc. has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 5, 2026
Date Received
Aug 7, 2026
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
510(k)

Source: FDA 510(k) database entry for K262812. Report a data issue: hello@regdatalab.com.