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510(k) K003272

FLO-BOOT by Discovery Group, LLC — Product Code BXB

K003272 is an FDA 510(k) premarket notification submitted by Discovery Group, LLC for the device "FLO-BOOT". The FDA issued a decision of Substantially Equivalent on April 4, 2001. 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
April 4, 2001
Date Received
October 18, 2000
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)
  • 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)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)

FDA data resources