Cleared Traditional

K963620 - 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS

K963620 is an FDA 510(k) clearance for 9TH WAVE MODELS 500 & 550 LOW AIR LOSS ..., manufactured by 9th Wave, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K963620 · 9th Wave, Inc. · General Hospital
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Jan 1997
Decision
119d
Days
Class 2
Risk

K963620 is an FDA 510(k) clearance for the 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by 9th Wave, Inc. (Mt Pleasant, US). The FDA issued a Cleared decision on January 7, 1997 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all 9th Wave, Inc. devices

FDA 510(k) Submission Details - K963620

510(k) Number K963620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date January 07, 1997
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 General Hospital devices follow this clearance model.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 51
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K963620.
EQUI-PISE 1000 MRS
K970350 · Advanced Air Support Consultancy, Inc. · Apr 1997
LUMEX AIR
K963674 · Lumex, Inc. · Jan 1997
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
K962585 · United Medical Equipment, Inc. · Jan 1997
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
K963510 · Mellen Air Mfg., Inc. · Nov 1996
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
K963626 · 9th Wave, Inc. · Nov 1996
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
K963677 · 9th Wave, Inc. · Nov 1996