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510(k) K790527

BURNETT-KETCHUM DYNAMIC HAND EXERCISER by Maddak, Inc. — Product Code JFA

K790527 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "BURNETT-KETCHUM DYNAMIC HAND EXERCISER". The FDA issued a decision of Substantially Equivalent on March 22, 1979. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1979
Date Received
March 15, 1979
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 Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

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)
  • K844033 — MOBILIMB HAND UNIT (November 27, 1984)

FDA data resources