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510(k) K931016

JACE MODEL H440 HAND CPM DEVICE by Jace Systems, Inc. — Product Code JFA

K931016 is an FDA 510(k) premarket notification submitted by Jace Systems, Inc. for the device "JACE MODEL H440 HAND CPM DEVICE". The FDA issued a decision of Substantially Equivalent on June 22, 1994. The device falls under product code JFA (Exerciser, Finger, Powered), a Class I device regulated under 21 CFR 890.5410. Jace Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1994
Date Received
February 26, 1993
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 Jace Systems, Inc.

  • K933059 — ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. (June 22, 1994)
  • K931781 — JACE TRI-STIM DEVICE (October 8, 1993)
  • K922185 — JACE KNEE EXTENSION SYSTEM -- MODIFICATION (June 11, 1992)
  • K921351 — JACE MODEL PM-410 HAND CPM DEVICE (May 4, 1992)
  • K920380 — JACE MODEL W550 WRIST CPM DEVICE (February 11, 1992)

Other clearances for product code JFA

  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • 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)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)

FDA data resources