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510(k) K240981

Air compression leg massager by Huizhou Xinyi Technology Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
April 10, 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

Other clearances by Huizhou Xinyi Technology Co., Ltd.

  • K221862 — YY-A02-B Overlapped Compression Therapy (December 8, 2022)

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  • K253150 — Cryon-X Cold Compression (October 24, 2025)
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