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510(k) K953456

E-Z FLEX by Fluid Motion Biotechnologies, Inc. — Product Code BXB

K953456 is an FDA 510(k) premarket notification submitted by Fluid Motion Biotechnologies, Inc. for the device "E-Z FLEX". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
July 19, 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 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)
  • 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)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)

FDA data resources