Cleared Traditional

K964246 - NOVABED PATIENT TRANSFER SYSTEM

K964246 is an FDA 510(k) clearance for NOVABED PATIENT TRANSFER SYSTEM, manufactured by Nova Technology Corp.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964246 · Nova Technology Corp. · General Hospital
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Jan 1997
Decision
90d
Days
Class 2
Risk

K964246 is an FDA 510(k) clearance for the NOVABED PATIENT TRANSFER SYSTEM. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Nova Technology Corp. (Washington, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Nova Technology Corp. devices

FDA 510(k) Submission Details - K964246

510(k) Number K964246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date January 22, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

All 27
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K964246.
VAIL 3000 BED ENCLOSURE
K963589 · Vail Products, Inc. · Apr 1997
TOTALCARE
K962942 · Hill-Rom, Inc. · Feb 1997
SOMA SAFE ENCLOSURE
K963701 · Nova Technology Corp. · Jan 1997
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · M.C. Healthcare Products, Inc. · Dec 1996
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
K962250 · Carroll Healthcare, Inc. · Oct 1996
2000 MODULAR THIRTY-NINE
K962763 · Equi-Tron Mfg., Inc. · Oct 1996