510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933418Substantially Equivalent

Hand Therapy Assost

Bardon Ent., Inc., Hampton VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933418 is the FDA 510(k) clearance record for HAND THERAPY ASSOST, a class I device, cleared for Bardon Ent., Inc. on under FDA product code JFA (Exerciser, Finger, Powered). FDA records list one 510(k) clearance for Bardon Ent., Inc. As of , FDA records show no recalls naming K933418.

Clearance record

Decision date
Received
(289 days to decision)
Product code
JFA Exerciser, Finger, Powered
Regulation
21 CFR 890.5410
Device class
Class I
Review panel
Physical Medicine
Applicant
Bardon Ent., Inc. 313 Orange Plank Rd., Hampton VA
510(k) summary
Summary
Third party review
No

Clearances, product code JFA

Trailing 12 months

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

FDA records show no clearances under product code JFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFA, 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