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510(k) K920380

JACE MODEL W550 WRIST CPM DEVICE by Jace Systems, Inc. — Product Code BXB

K920380 is an FDA 510(k) premarket notification submitted by Jace Systems, Inc. for the device "JACE MODEL W550 WRIST CPM DEVICE". The FDA issued a decision of Substantially Equivalent on February 11, 1992. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Jace Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1992
Date Received
January 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Jace Systems, Inc.

  • K933059 — ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. (June 22, 1994)
  • K931016 — JACE MODEL H440 HAND CPM DEVICE (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)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources