Cleared Traditional

CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (K951414) - FDA 510(k) Clearance

Class I Physical Medicine device.

K951414 · Champion Mfg. Corp. · Physical Medicine device
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Aug 1995
Decision
137d
Days
Class 1
Risk

K951414 is an FDA 510(k) clearance for the CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Champion Mfg. Corp. (Shipshewana, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 Champion Mfg. Corp. devices

Submission Details

510(k) Number K951414 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 27, 1995
Decision Date August 11, 1995
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K951414.
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