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510(k) K935808

REVOLUTION LOWER LIMB CPM UNIT by Toronto Medical, Inc. — Product Code BXB

K935808 is an FDA 510(k) premarket notification submitted by Toronto Medical, Inc. for the device "REVOLUTION LOWER LIMB CPM UNIT". The FDA issued a decision of Substantially Equivalent on March 18, 1994. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Toronto Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1994
Date Received
December 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Toronto Medical, Inc.

  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)
  • K945121 — A3 ANKLE CPM UNIT (February 17, 1995)
  • K935587 — MULTILINK SHOULDER CPM UNIT (December 14, 1994)
  • K935841 — DR KOOL (August 29, 1994)
  • K925926 — MOBILIMB T1 TOE CPM UNIT (March 22, 1993)
  • K900466 — MOBILIMB W1 WRIST CPM UNIT (March 12, 1990)
  • K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT (March 12, 1990)
  • K900794 — MOBILIMB H3 HAND CPM UNIT (March 2, 1990)
  • K895720 — MOBILIMB J1 TMJ CPM UNIT (January 4, 1990)
  • K891345 — MOBILIMB CPM SHOULDER UNIT (April 24, 1989)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources