Cleared Traditional

K810676 - CONVAID CRUISER CP4M
(FDA 510(k) Clearance)

Mar 1981
Decision
14d
Days
Class 1
Risk

K810676 is an FDA 510(k) clearance for the CONVAID CRUISER CP4M. 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 March 26, 1981, 14 days after receiving the submission on March 12, 1981.

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

Submission Details

510(k) Number K810676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1981
Decision Date March 26, 1981
Days to Decision 14 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