Cleared Traditional

K923942 - RHOMBO MEDICAL RHOMBO-FILL

K923942 is an FDA 510(k) clearance for RHOMBO MEDICAL RHOMBO-FILL, manufactured by International Medical Products, Inc.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K923942 · International Medical Products, Inc. · Physical Medicine device
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Mar 1993
Decision
231d
Days
Class 1
Risk

K923942 is an FDA 510(k) clearance for the RHOMBO MEDICAL RHOMBO-FILL. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 231 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K923942

510(k) Number K923942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date March 24, 1993
Days to Decision 231 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
115d slower than avg
Panel avg: 116d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 49
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K923942.
ALDEN WHEELCHAIR CUSHION
K942260 · Ward and Assoc. · May 1994
ALDEN LINEAGE WHEELCHAIR CUSHION
K942312 · Lewis W. Ward · May 1994
ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION
K933051 · General Components Intl., Inc. · Oct 1993
PM
K925980 · Pathfinder Intl. Corp. · Mar 1993
TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST
K923364 · Labac Systems, Inc. · Mar 1993
TILT SEATING SYSTEM
K923366 · Labac Systems, Inc. · Feb 1993
K923942 · RHOMBO MEDICAL RHOMBO-FILL
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