Home / 510(k) Clearances / K961425

510(k) K961425

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS by Bio Compression Systems, Inc. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1996
Date Received
April 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

Other clearances by Bio Compression Systems, Inc.

  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-D (February 16, 2022)
  • K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-D (May 14, 2021)
  • K180248 — VascuEase IC-1200-WH (August 7, 2018)
  • K171793 — Sequential Circulator SC-2004FC-OC (August 17, 2017)
  • K150953 — Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (July 16, 2015)
  • K142640 — Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulato (November 6, 2014)
  • K131306 — IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE (July 22, 2013)
  • K131327 — BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (July 18, 2013)
  • K122112 — 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM (April 9, 2013)

Other clearances for product code ILO

  • K213097 — Armory Motion (June 10, 2022)
  • K083008 — COOLSKIN (June 10, 2009)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE (September 7, 2007)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K040317 — IVC SYSTEM (May 7, 2004)
  • K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (November 3, 1997)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)