Class I Physical Medicine device.
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.
| 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 |
| Product Code | IPS Cane |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 890.3075 |
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.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.