Cleared Traditional

K790299 - FOREARM-CANE
(FDA 510(k) Clearance)

K790299 · Guardian Products Co., Inc. · Physical Medicine
Feb 1979
Decision
9d
Days
Class 1
Risk

K790299 is an FDA 510(k) clearance for the FOREARM-CANE, a Cane (Class I — General Controls, product code IPS), submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1979, 9 days after receiving the submission on February 12, 1979. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3075.

Submission Details

510(k) Number K790299 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1979
Decision Date February 21, 1979
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IPS — Cane
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3075