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510(k) K950682

W2 WRIST CPM UNIT by Toronto Medical Corp. — Product Code BXB

K950682 is an FDA 510(k) premarket notification submitted by Toronto Medical Corp. for the device "W2 WRIST CPM UNIT". The FDA issued a decision of Substantially Equivalent on September 13, 1995. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Toronto Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1995
Date Received
February 14, 1995
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 Corp.

  • K945121 — A3 ANKLE CPM UNIT (February 17, 1995)
  • K935587 — MULTILINK SHOULDER CPM UNIT (December 14, 1994)
  • K935841 — DR KOOL (August 29, 1994)
  • K935808 — REVOLUTION LOWER LIMB CPM UNIT (March 18, 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