Cleared Traditional

K821402 - LIGHT WEIGHT ALUMINUM CANES

K821402 is an FDA 510(k) clearance for LIGHT WEIGHT ALUMINUM CANES, manufactured by Manuco Manufacturing Co., Inc.. The device is a Class 1 Physical Medicine device with product code IPS cleared through the Traditional 510(k) pathway .

K821402 · Manuco Manufacturing Co., Inc. · Physical Medicine device
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Apr 1982
Decision
-
Days
Class 1
Risk

K821402 is an FDA 510(k) clearance for the LIGHT WEIGHT ALUMINUM CANES. Classified as Cane (product code IPS), Class I - General Controls.

Submitted by Manuco Manufacturing Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3075 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Manuco Manufacturing Co., Inc. devices

FDA 510(k) Submission Details - K821402

510(k) Number K821402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1982
Decision Date April 21, 1982
Days to Decision -
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

IPS Device Classification - Class 1, General Controls

Product Code IPS Cane
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.