510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130644Substantially Equivalent

Pediatric Folding Wheelchair

Columbia Medical Mfg, LLC, Santa Fe Springs CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130644 is the FDA 510(k) clearance record for PEDIATRIC FOLDING WHEELCHAIR, a class I device, cleared for Columbia Medical Mfg, LLC on under FDA product code LBE (Stroller, Adaptive). FDA records list one 510(k) clearance for Columbia Medical Mfg, LLC. As of , FDA records show no recalls naming K130644.

Clearance record

Decision date
Received
(219 days to decision)
Product code
LBE Stroller, Adaptive
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Columbia Medical Mfg, LLC 11724 Willake St., Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBE

Trailing 12 months

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

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