Cleared Traditional

K911574 - PNEU-WAVE

K911574 is an FDA 510(k) clearance for PNEU-WAVE, manufactured by Pneu-Mobility, Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K911574 · Pneu-Mobility, Inc. · Physical Medicine device
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Oct 1991
Decision
177d
Days
Class 2
Risk

K911574 is an FDA 510(k) clearance for the PNEU-WAVE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Pneu-Mobility, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 177 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Pneu-Mobility, Inc. devices

FDA 510(k) Submission Details - K911574

510(k) Number K911574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date October 02, 1991
Days to Decision 177 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
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 33
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K911574.
TRUE-TRAC, STRATUS
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K900304 · Chattanooga Group, Inc. · Apr 1990
HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K862022 · Lic-Orthion · Jun 1986