510(k) K221862
K221862 is an FDA 510(k) premarket notification submitted by Huizhou Xinyi Technology Co., Ltd. for the device "YY-A02-B Overlapped Compression Therapy". The FDA issued a decision of Substantially Equivalent on December 8, 2022. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Huizhou Xinyi Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2022
- Date Received
- June 27, 2022
- 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