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510(k) K890200

PNEUMATIC DORSIFLEXOR by Medical Flotation Systems, Inc. — Product Code BXB

K890200 is an FDA 510(k) premarket notification submitted by Medical Flotation Systems, Inc. for the device "PNEUMATIC DORSIFLEXOR". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Medical Flotation Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
January 18, 1989
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 Medical Flotation Systems, Inc.

  • K893801 — M.F.S. LOW AIR LOSS PULSATING BED (July 25, 1989)
  • K884908 — ULTRAFLOTATION MEDICAL WHEELCHAIR (December 27, 1988)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)
  • K882607 — ULTRAFLOTATION BED (October 14, 1988)

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)
  • K953456 — E-Z FLEX (January 26, 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)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources