Cleared Traditional

K951414 - CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR

K951414 is an FDA 510(k) clearance for CHAMPION PHYSIOACOUSTICC RECLINER-TRANS..., manufactured by Champion Mfg. Corp.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 137-day FDA review.

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

FDA 510(k) Submission Details - K951414

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.

IRO Device Classification - Class 1, General Controls

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 22
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