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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 Feb 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 110 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 20, 1990
Date Received
Feb 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
510(k) Exempt

Other clearances by Buckman Co., Inc.

  • K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (Jun 25, 1998)
  • K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM (Jun 8, 1998)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (Jan 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (Apr 18, 1996)
  • K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS (Jan 25, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (Dec 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (Oct 19, 1995)
  • K951117 — LIHTAN 532 LASER (Oct 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (Feb 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 (Jun 22, 1994)
  • K933418 — HAND THERAPY ASSOST (Apr 28, 1994)
  • K921351 — JACE MODEL PM-410 HAND CPM DEVICE (May 4, 1992)
  • K900794 — MOBILIMB H3 HAND CPM UNIT (Mar 2, 1990)
  • K880686 — TORONTO/MOBILIMB HAND C.P.M. (Feb 26, 1988)
  • K880336 — MOBILIMB HAND C.P.M. UNIT (Feb 16, 1988)
  • K860714 — ACE AIM - CPM HAND UNIT (Mar 27, 1986)
  • K844033 — MOBILIMB HAND UNIT (Nov 27, 1984)
  • K830974 — SUTTER CPM 5000 (Apr 12, 1983)

FDA data resources

Source: FDA 510(k) database entry for K900581. Report a data issue: hello@regdatalab.com.