510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K905013Substantially Equivalent

T.c.s. Total Contact Seat

Fundamental Products Co., No. Hollywood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905013 is the FDA 510(k) clearance record for T.C.S. TOTAL CONTACT SEAT, a class I device, cleared for Fundamental Products Co. on under FDA product code KNN (Components, Wheelchair). FDA records list one 510(k) clearance for Fundamental Products Co. As of , FDA records show no recalls naming K905013.

Clearance record

Decision date
Received
(43 days to decision)
Product code
KNN Components, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Fundamental Products Co. 10440 Burbank Blvd., No. Hollywood CA
Third party review
No

Clearances, product code KNN

Trailing 12 months

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

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