Cleared Traditional

K862957 - MERIVAARA GERIATRIC CHAIR MODEL 455

K862957 is an FDA 510(k) clearance for MERIVAARA GERIATRIC CHAIR MODEL 455, manufactured by Global Medical Prods, Inc.. The device is a Class 1 Physical Medicine device with product code INN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K862957 · Global Medical Prods, Inc. · Physical Medicine device
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Aug 1986
Decision
15d
Days
Class 1
Risk

K862957 is an FDA 510(k) clearance for the MERIVAARA GERIATRIC CHAIR MODEL 455. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Global Medical Prods, Inc. (Chicago, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 15 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 - K862957

510(k) Number K862957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1986
Decision Date August 21, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
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 21
Devices cleared under the same product code (INN) and FDA review panel - the closest regulatory comparables to K862957.
CORNER SEAT
K894767 · Canadian Posture and Seating Centre, Inc. · Jan 1990
HIP SAVER
K882090 · Pride Health Care, Inc. · May 1988
CONVERTA-LITTER
K874060 · Camtec · Dec 1987
ORTHOPEDIC SEATS
K862883 · Mednet, Inc. · Aug 1986
CAR SEAT
K862885 · Mednet, Inc. · Aug 1986
SPLIT SEAT POSITIONING CHAIR
K841691 · Maddak, Inc. · May 1984
K862957 · MERIVAARA GERIATRIC CHAIR MODEL 455
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