Cleared Traditional

NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC (K923186) - FDA 510(k) Clearance

Class I Physical Medicine device.

K923186 · Roho, Inc. · Physical Medicine device
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Sep 1992
Decision
71d
Days
Class 1
Risk

K923186 is an FDA 510(k) clearance for the NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Roho, Inc. (Belleville, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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 Roho, Inc. devices

Submission Details

510(k) Number K923186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1992
Decision Date September 09, 1992
Days to Decision 71 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 63
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K923186.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · Fred Sammons, Inc. · Jan 1982
DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · Fred Sammons, Inc. · Sep 1981