510(k) K212713
K212713 is an FDA 510(k) premarket notification submitted by Xiamen High Top Electronic Technology Co., Ltd. for the device "Air compression leg massager HY-1117A". The FDA issued a decision of Substantially Equivalent on Jan 18, 2022. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Xiamen High Top Electronic Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2022
- Date Received
- Aug 26, 2021
- 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)