Cleared Traditional

MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS (K932240) - FDA 510(k) Clearance

Class I Physical Medicine device.

K932240 · Bailey Mfg. Co. · Physical Medicine device
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Apr 1994
Decision
329d
Days
Class 1
Risk

K932240 is an FDA 510(k) clearance for the MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS. Classified as Bars, Parallel, Powered (product code IRR), Class I - General Controls.

Submitted by Bailey Mfg. Co. (Lodi, US). The FDA issued a Cleared decision on April 1, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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. Elevated predicate reliance profile. 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 Bailey Mfg. Co. devices

Submission Details

510(k) Number K932240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date April 01, 1994
Days to Decision 329 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 115d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRR Bars, Parallel, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.