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510(k) K931128

BASIC SHOULDER CPM by Danninger Medical Technology, Inc. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1994
Date Received
March 5, 1993
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 Danninger Medical Technology, Inc.

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

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  • K953456 — E-Z FLEX (January 26, 1996)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)