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510(k) K241446

Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) by Sichuan Qianii-Beoka Medical Technoiogy Lnc. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2024
Date Received
May 22, 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

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