Cleared Traditional

WALL GRAB BARS 98130-98136

K842650 · Guardian Products Co., Inc. · Physical Medicine
Aug 1984
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K842650 is an FDA 510(k) clearance for the WALL GRAB BARS 98130-98136, a Aid, Transfer (Class I — General Controls, product code IKX), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 31 days after receiving the submission on July 10, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K842650 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1984
Decision Date August 10, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IKX — Aid, Transfer
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050