Cleared Traditional

K922045 - SHOWER CHAIRS

K922045 is an FDA 510(k) clearance for SHOWER CHAIRS, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 1 Physical Medicine device with product code INM cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K922045 · Medical Device Inspection Co., Inc. · Physical Medicine device
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May 1992
Decision
25d
Days
Class 1
Risk

K922045 is an FDA 510(k) clearance for the SHOWER CHAIRS. Classified as Chair, With Casters (product code INM), Class I - General Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on May 26, 1992 after a review of 25 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 - K922045

510(k) Number K922045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date May 26, 1992
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 116d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

INM Device Classification - Class 1, General Controls

Product Code INM Chair, With Casters
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 - INM Chair, With Casters

All 34
Devices cleared under the same product code (INM) and FDA review panel - the closest regulatory comparables to K922045.
KAYE SCOOT-ABOUT, MODEL SB1
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DOLOMITE ROLLATOR
K921917 · Seamark Technologies · May 1992
AMBULATOR
K921752 · The Anthros Medical Group · May 1992
RIFTON MOR219 19 & RIFTON MOR225 25
K921817 · Rifton Equipment For the Handicapped · Apr 1992
DUKKI
K913544 · Pin Dot Products, Inc. · Aug 1991
K922045 · SHOWER CHAIRS
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