Cleared Traditional

K830427 - ARM CUSHION

K830427 is an FDA 510(k) clearance for ARM CUSHION, manufactured by Maddak, Inc.. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K830427 · Maddak, Inc. · Physical Medicine device
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Mar 1983
Decision
48d
Days
Class 1
Risk

K830427 is an FDA 510(k) clearance for the ARM CUSHION. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3175 - 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.

FDA 510(k) Submission Details - K830427

510(k) Number K830427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date March 29, 1983
Days to Decision 48 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
68d faster than avg
Panel avg: 116d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

KIC Device Classification - Class 1, General Controls

Product Code KIC Cushion, Flotation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3175
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 - KIC Cushion, Flotation

All 28
Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K830427.
JAY CUSHION
K834517 · Jay Medical, Ltd. · Jan 1984
SAFE-SEAT WHEELCHAIR CUSHION
K831247 · D.A. Schulman, Inc. · May 1983
INFLATABLE INVALID RING
K830426 · Maddak, Inc. · Apr 1983
RUBBER INFLATABLE RING
K823903 · Duro-Med Ind., Inc. · Jan 1983
WATER FLOATATION PAD
K820236 · Gottfried Medical, Inc. · Feb 1982
GEL FLOTATION CUSHION
K813225 · Jefferson Industries, Inc. · Dec 1981
K830427 · ARM CUSHION
Download PDF Maddak, Inc.