Cleared Traditional

STANDEX (K885343) - FDA 510(k) Clearance

Class I Physical Medicine device.

K885343 · Alt, Inc. · Physical Medicine device
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May 1989
Decision
124d
Days
Class 1
Risk

K885343 is an FDA 510(k) clearance for the STANDEX. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Alt, Inc. (Redwood Falls, US). The FDA issued a Cleared decision on May 1, 1989 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - 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 Alt, Inc. devices

Submission Details

510(k) Number K885343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date May 01, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 115d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ION Exerciser, Non-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
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.

Regulatory Peers - ION Exerciser, Non-measuring

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