510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K895343Substantially Equivalent

Prenatal Wedge

Kay Ent., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895343 is the FDA 510(k) clearance record for PRENATAL WEDGE, a class II device, cleared for Kay Ent. on under FDA product code JFB (Table, Physical Therapy, Multi Function). FDA records list one 510(k) clearance for Kay Ent. As of , FDA records show no recalls naming K895343.

Clearance record

Decision date
Received
(28 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
Kay Ent. 7701 E. Pima, Tucson AZ
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