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510(k) K900794

MOBILIMB H3 HAND CPM UNIT by Toronto Medical Corp. — Product Code JFA

K900794 is an FDA 510(k) premarket notification submitted by Toronto Medical Corp. for the device "MOBILIMB H3 HAND CPM UNIT". The FDA issued a decision of Substantially Equivalent on March 2, 1990. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Toronto Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1990
Date Received
February 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Finger, Powered
Device Class
Class I
Regulation Number
890.5410
Review Panel
PM
Submission Type

Other clearances by Toronto Medical Corp.

  • 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)
  • 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)
  • K895720 — MOBILIMB J1 TMJ CPM UNIT (January 4, 1990)
  • K891345 — MOBILIMB CPM SHOULDER UNIT (April 24, 1989)

Other clearances for product code JFA

  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • K931016 — JACE MODEL H440 HAND CPM DEVICE (June 22, 1994)
  • K933418 — HAND THERAPY ASSOST (April 28, 1994)
  • K921351 — JACE MODEL PM-410 HAND CPM DEVICE (May 4, 1992)
  • K900581 — DANNIFLEX CPM 880(TM) (February 20, 1990)
  • K880686 — TORONTO/MOBILIMB HAND C.P.M. (February 26, 1988)
  • K880336 — MOBILIMB HAND C.P.M. UNIT (February 16, 1988)
  • K860714 — ACE AIM - CPM HAND UNIT (March 27, 1986)
  • K844033 — MOBILIMB HAND UNIT (November 27, 1984)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)

FDA data resources