Cleared Traditional

K840250 - CARRIER
(FDA 510(k) Clearance)

Feb 1984
Decision
29d
Days
Class 1
Risk

K840250 is an FDA 510(k) clearance for the CARRIER. This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).

Submitted by Convaid Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984, 29 days after receiving the submission on January 11, 1984.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number K840250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1984
Decision Date February 09, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code LBE — Stroller, Adaptive
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3850