510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924848Substantially Equivalent

Kaye Scoot-About, Model Sb1

Kaye Products, Inc., Hillsborough NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924848 is the FDA 510(k) clearance record for KAYE SCOOT-ABOUT, MODEL SB1, a class I device, cleared for Kaye Products, Inc. on under FDA product code INM (Chair, With Casters). FDA records list 12 510(k) clearances for Kaye Products, Inc., from to . As of , FDA records show no recalls naming K924848.

Clearance record

Decision date
Received
(137 days to decision)
Product code
INM Chair, With Casters
Regulation
21 CFR 890.3100
Device class
Class I
Review panel
Physical Medicine
Applicant
Kaye Products, Inc. 535 Dimmocks Mill Rd., Hillsborough NC
510(k) summary
Statement
Third party review
No

Clearances, product code INM

Trailing 12 months

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

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