510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971046Substantially Equivalent

Handiflex

Handiflex Corp., Davie FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971046 is the FDA 510(k) clearance record for HANDIFLEX, a class II device, cleared for Handiflex Corp. on under FDA product code JFB (Table, Physical Therapy, Multi Function). FDA records list one 510(k) clearance for Handiflex Corp. As of , FDA records show no recalls naming K971046.

Clearance record

Decision date
Received
(179 days to decision)
Product code
JFB Table, Physical Therapy, Multi Function
Regulation
21 CFR 890.5880
Device class
Class II
Review panel
Physical Medicine
Applicant
Handiflex Corp. 4611 S. University Dr., Davie FL
510(k) summary
Statement
Third party review
No

Clearances, product code JFB

Trailing 12 months

FDA records hold no clearances under product code JFB in the trailing twelve months.

FDA records show no clearances under product code JFB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260