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510(k) K830316

UNIFLEX by Buckman Consultants — Product Code BXB

K830316 is an FDA 510(k) premarket notification submitted by Buckman Consultants for the device "UNIFLEX". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Buckman Consultants has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
January 31, 1983
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 Buckman Consultants

  • K823882 — M-BRACE (January 17, 1983)
  • K821829 — UROGARD (July 30, 1982)

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)
  • 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)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources