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FDA 510(k)

PEDIATRIC FOLDING WHEELCHAIR

K-Number: K130644 · 2013-10-16

ApplicantColumbia Medical Mfg, LLC
Decision Date2013-10-16
Product CodeLBE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC FOLDING WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Medical Mfg, LLC. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K130644. The device is classified under product code LBE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC FOLDING WHEELCHAIR?

PEDIATRIC FOLDING WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Columbia Medical Mfg, LLC. The 510(k) number is K130644.

When did PEDIATRIC FOLDING WHEELCHAIR receive FDA 510(k) clearance?

PEDIATRIC FOLDING WHEELCHAIR received FDA 510(k) clearance on 2013-10-16, under 510(k) number K130644.

Who is the listed applicant for PEDIATRIC FOLDING WHEELCHAIR?

The FDA 510(k) record lists Columbia Medical Mfg, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC FOLDING WHEELCHAIR?

The FDA product code for PEDIATRIC FOLDING WHEELCHAIR is LBE.

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Related Devices (Code: LBE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223533Little Wave Arc; Little Wave FlipKi Mobility, LLCK863450SULKY SPECIALAsc Corp.K862888PERAMBULATOR (STROLLER)Mednet, Inc.K840250CARRIERConvaid Products, Inc.K820591MECHANICAL CHAIRKaye Products, Inc.K810676CONVAID CRUISER CP4MConvaid Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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