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510(k) K900581

DANNIFLEX CPM 880(TM) by Buckman Co., Inc. — Product Code JFA

K900581 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "DANNIFLEX CPM 880(TM)". The FDA issued a decision of Substantially Equivalent on February 20, 1990. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1990
Date Received
February 7, 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 Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (June 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (June 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (January 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)

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)
  • K900794 — MOBILIMB H3 HAND CPM UNIT (March 2, 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