510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861943Substantially Equivalent

Pci Custom Design Series

Poston & Cole Intl., Berkeley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861943 is the FDA 510(k) clearance record for PCI CUSTOM DESIGN SERIES, a class II device, cleared for Poston & Cole Intl. on under FDA product code IQC (Wheelchair, Special Grade). FDA records list one 510(k) clearance for Poston & Cole Intl. As of , FDA records show no recalls naming K861943.

Clearance record

Decision date
Received
(10 days to decision)
Product code
IQC Wheelchair, Special Grade
Regulation
21 CFR 890.3880
Device class
Class II
Review panel
Physical Medicine
Applicant
Poston & Cole Intl. 2550 Ninth St., Suite 111, Berkeley CA
Third party review
No

Clearances, product code IQC

Trailing 12 months

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

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