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510(k) K250190

Sequential Compression System (SCD600) by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code JOW

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

Other clearances by Shenzhen Comen Medical Instruments Co.,Ltd

  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K211619 — Multi-Parameter Patient Monitor (December 29, 2022)
  • K191106 — C50 and C80 Multi-parameter Patient Monitor (December 13, 2019)
  • K173454 — Multi-parameter Patient Monitor, models C30 (August 16, 2018)

Other clearances for product code JOW

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)
  • K232640 — Venowave VW5 (June 25, 2024)