Cleared Traditional

BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF (K801709) - FDA 510(k) Clearance

Class I Physical Medicine device.

K801709 · Fred Sammons, Inc. · Physical Medicine device
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Aug 1980
Decision
14d
Days
Class 1
Risk

K801709 is an FDA 510(k) clearance for the BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF. Classified as Accessories, Wheelchair (product code KNO), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3910 - 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: 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K801709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 07, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNO Accessories, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3910
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 - KNO Accessories, Wheelchair

All 24
Devices cleared under the same product code (KNO) and FDA review panel - the closest regulatory comparables to K801709.
WHEELCHAIR ACCESSORIES
K811491 · Fred Sammons, Inc. · Jun 1981
BODY STRAP
K810439 · Fred Sammons, Inc. · Mar 1981
WHEELCHAIR ACCESSORIES
K810448 · Fred Sammons, Inc. · Mar 1981
ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT
K790176 · Fred Sammons, Inc. · Feb 1979
ASHTRAY FOR WHEELCHAIR
K790177 · Fred Sammons, Inc. · Feb 1979
BAG, WHEELCHAIR
K781194 · Fred Sammons, Inc. · Jul 1978