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510(k) K952975

ANKLE CALF EXERCISER PHLEBOPUMP by Prevent Products, Inc. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1996
Date Received
June 27, 1995
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 Prevent Products, Inc.

  • K003284 — PHLEBOPUMP, MODEL 1000 (January 17, 2001)
  • K942618 — ANKLE CALF EXERCISER (June 22, 1994)

Other clearances for product code BXB

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  • 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)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)