510(k) K250244
K250244 is an FDA 510(k) premarket notification submitted by Guangzhou Longest Medical Technology Co., Ltd. for the device "Compression Therapy Device (LGT-2210DS)". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Guangzhou Longest Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2025
- Date Received
- January 27, 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