510(k) K251623
K251623 is an FDA 510(k) premarket notification submitted by Shenzhen Yicai Health Technology Co., Ltd. for the device "Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Shenzhen Yicai Health Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2025
- Date Received
- May 28, 2025
- 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