Cleared Traditional

K932240 - MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS

K932240 is an FDA 510(k) clearance for MODEL 5200-10, manufactured by Bailey Mfg. Co.. The device is a Class 1 Physical Medicine device with product code IRR cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K932240

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.

IRR Device Classification - Class 1, General Controls

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.