510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942397Substantially Equivalent

Theradapt Highchair/stroller Insert

Theradapt Products Inc., Bensenville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942397 is the FDA 510(k) clearance record for THERADAPT HIGHCHAIR/STROLLER INSERT, a class I device, cleared for Theradapt Products, Inc. on under FDA product code INN (Chair, Adjustable, Mechanical). FDA records list 5 510(k) clearances for Theradapt Products, Inc., from to . As of , FDA records show no recalls naming K942397.

Clearance record

Decision date
Received
(34 days to decision)
Product code
INN Chair, Adjustable, Mechanical
Regulation
21 CFR 890.3100
Device class
Class I
Review panel
Physical Medicine
Applicant
Theradapt Products, Inc. 17 W. 163 Oak Ln., Bensenville IL
510(k) summary
Statement
Third party review
No

Clearances, product code INN

Trailing 12 months

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

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