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510(k) K122112

2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM by Bio Compression Systems, Inc. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2013
Date Received
July 17, 2012
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

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)
  • K072666 — BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (November 5, 2007)

Other clearances for product code IRP

  • K251622 — Hand Massager (SM004D) (January 28, 2026)
  • K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) (November 13, 2025)
  • K251531 — AIR COMPRESSION BOOTS 1018195,1018196 (October 30, 2025)
  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K251905 — Normatec Elite Hip (September 18, 2025)
  • K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (September 17, 2025)
  • K250244 — Compression Therapy Device (LGT-2210DS) (July 25, 2025)
  • K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compress (July 23, 2025)
  • K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (May 5, 2025)
  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)