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510(k) K914860

SUTTER MODEL 10000 LEG CPM DEVICE by Sutter Corp. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1992
Date Received
October 29, 1991
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

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  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)
  • K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT (February 22, 1993)
  • K902707 — MODEL 9000 AT ANKLE CPM DEVICE (July 25, 1990)
  • K890607 — SUTTER HOSPITAL CPM (February 27, 1989)

Other clearances for product code BXB

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  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • 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)