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510(k) K010744

FLOWTRON UNIVERSAL, MODEL AC600 by Huntleigh Healthcare, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2002
Date Received
March 13, 2001
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

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  • K152228 — Hydroven 12, Hydroven 12 Garments (April 4, 2016)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)
  • K090285 — SONICAID FM820 AND FM830 ENCORE (July 15, 2009)
  • K081572 — SMARTSIGNS MINPULSE (October 1, 2008)
  • K060230 — DOPPLEX CENTRALE (March 23, 2006)
  • K053369 — MEDILOG DARWIN HOLTER ANALYSIS (December 22, 2005)

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)
  • K250190 — Sequential Compression System (SCD600) (December 8, 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)