Cleared Traditional

K922550 - ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)

K922550 is an FDA 510(k) clearance for ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM), manufactured by Verimed Holdings, Inc.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K922550 · Verimed Holdings, Inc. · Neurology device
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Dec 1992
Decision
195d
Days
Class 1
Risk

K922550 is an FDA 510(k) clearance for the ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM). Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Verimed Holdings, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 195 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K922550

510(k) Number K922550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date December 10, 1992
Days to Decision 195 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 149d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
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 - KQX Goniometer, Ac-powered

All 32
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K922550.
THE BTE VECTOR
K925225 · Baltimore Therapeutic Equipment Co. · Jun 1994
ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA
K933063 · Isotechnologies, Inc. · Jan 1994
BOOST, MICE, GAMESYS.
K924416 · Penny and Giles Biometrics , Ltd. · Jun 1993
SPINE MOTION ANALYZER WITH EMG
K920256 · Orthopedic Systems, Inc. · Aug 1992
NOROTRACK 360 INCLINOMETER
K920690 · Noromed, Inc. · May 1992
RANGE OF MOTION SENSOR, MODEL RM001
K914060 · Nk Biotechnical Engineering Co. · Dec 1991
K922550 · ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
Download PDF Verimed Holdings, Inc.