Cleared Traditional

K841691 - SPLIT SEAT POSITIONING CHAIR

K841691 is an FDA 510(k) clearance for SPLIT SEAT POSITIONING CHAIR, manufactured by Maddak, Inc.. The device is a Class 1 Physical Medicine device with product code INN cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K841691 · Maddak, Inc. · Physical Medicine device
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May 1984
Decision
16d
Days
Class 1
Risk

K841691 is an FDA 510(k) clearance for the SPLIT SEAT POSITIONING CHAIR. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - 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 - K841691

510(k) Number K841691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date May 09, 1984
Days to Decision 16 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
100d faster than avg
Panel avg: 116d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

INN Device Classification - Class 1, General Controls

Product Code INN Chair, Adjustable, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
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 - INN Chair, Adjustable, Mechanical

All 25
Devices cleared under the same product code (INN) and FDA review panel - the closest regulatory comparables to K841691.
MERIVAARA GERIATRIC CHAIR MODEL 455
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RECLINING WHEELS
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THE PROGRESSIVE CHAIR
K823277 · Progressive Productions , Ltd. · Dec 1982
E-Z UP ARTHERAPEDIC CHAIR
K821651 · Medical Device Consultants, Inc. · Jun 1982
K841691 · SPLIT SEAT POSITIONING CHAIR
Download PDF Maddak, Inc.