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510(k) K844033

MOBILIMB HAND UNIT by Danninger Medical Technology, Inc. — Product Code JFA

K844033 is an FDA 510(k) premarket notification submitted by Danninger Medical Technology, Inc. for the device "MOBILIMB HAND UNIT". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Danninger Medical Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1984
Date Received
October 15, 1984
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 Danninger Medical Technology, Inc.

  • K931128 — BASIC SHOULDER CPM (May 6, 1994)
  • K933394 — DANNIFLEX CPM 600 (March 11, 1994)
  • K913026 — TTU-100THERMAL THERAPY UNIT (December 13, 1991)
  • K875223 — DANNINGER ORTHOPAEDIC AWL (February 17, 1988)
  • K862730 — DANNIFLEX 400SL (July 24, 1986)

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)
  • 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)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)

FDA data resources