Air Compression Massager (HY-1165)— 510(k) K260529
Substantially EquivalentXiamen High Top Electronic Technology Co., Ltd.
FDA 510(k) clearance K260529 for Air Compression Massager (HY-1165), Substantially Equivalent on 2026-07-27. Applicant: Xiamen High Top Electronic Technology Co., Ltd.. Device class: 2.
Summary
Xiamen High Top Electronic Technology's Air Compression Massager (HY-1165) is filed under IRP, powered inflatable tube massagers. The record gives the model as HY-1165 but no specs.
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Xiamen, China. The decision came 160 calendar days after receipt (February 17 to July 27, 2026).
Clearance details
- Applicant
- Xiamen High Top Electronic Technology Co., Ltd.
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
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More clearances from Xiamen High Top Electronic Technology Co., Ltd.
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