510(k) K250190
K250190 is an FDA 510(k) premarket notification submitted by Shenzhen Comen Medical Instruments Co.,Ltd for the device "Sequential Compression System (SCD600)". The FDA issued a decision of Substantially Equivalent on December 8, 2025. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Shenzhen Comen Medical Instruments Co.,Ltd has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2025
- Date Received
- January 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type