Cleared Traditional

K963677 - 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD

K963677 is an FDA 510(k) clearance for 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD, 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 74-day FDA review.

K963677 · 9th Wave, Inc. · General Hospital
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Nov 1996
Decision
74d
Days
Class 2
Risk

K963677 is an FDA 510(k) clearance for the 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD. 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 November 26, 1996 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 9th Wave, Inc. devices

FDA 510(k) Submission Details - K963677

510(k) Number K963677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date November 26, 1996
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K963677.
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
K963620 · 9th Wave, 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
AIR-MEDEX I
K961769 · Robert Gold Assoc. · Oct 1996
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996