Cleared Traditional

K902795 - MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)

K902795 is an FDA 510(k) clearance for MODIFIED CHAIRS (DENTAL, manufactured by The Healthcare Group, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K902795 · The Healthcare Group, Inc. · Physical Medicine device
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Jul 1990
Decision
29d
Days
Class 2
Risk

K902795 is an FDA 510(k) clearance for the MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY). Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by The Healthcare Group, Inc. (West Valley, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - 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 - K902795

510(k) Number K902795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1990
Decision Date July 25, 1990
Days to Decision 29 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
87d faster than avg
Panel avg: 116d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 34
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K902795.
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K864366 · Invacare Corp. · Dec 1986
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K852812 · Invacare Corp. · Nov 1985
K902795 · MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)
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