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510(k) K920380

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

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.

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  • 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)

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