Cleared Traditional

K946229 - BALANCE MANAGER

K946229 is an FDA 510(k) clearance for BALANCE MANAGER, manufactured by Neurocom International, Inc.. The device is a Class 1 Physical Medicine device with product code KHX cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K946229 · Neurocom International, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
225d
Days
Class 1
Risk

K946229 is an FDA 510(k) clearance for the BALANCE MANAGER. Classified as Platform, Force-measuring (product code KHX), Class I - General Controls.

Submitted by Neurocom International, Inc. (Clackamas, US). The FDA issued a Cleared decision on August 4, 1995 after a review of 225 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1575 - 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 - K946229

510(k) Number K946229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date August 04, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 116d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

KHX Device Classification - Class 1, General Controls

Product Code KHX Platform, Force-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1575
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 - KHX Platform, Force-measuring

All 14
Devices cleared under the same product code (KHX) and FDA review panel - the closest regulatory comparables to K946229.
COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM
K951771 · Sms Technologies, Ltd. · Aug 1995
STABILITY SYSTEM (110V) MODEL 945-300
K942694 · Biodex Medical Systems, Inc. · Mar 1995
SMS BALANCE PERFORMANCE MONITOR
K930089 · Sms Technologies, Ltd. · Jun 1993
FORCE MEASURING PLATFORM
K921340 · Sra Intl., Inc. · May 1992
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
K901069 · Computerized Functional Testing Corp. · Mar 1990
DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER
K893254 · Dalphi, Inc. · Jan 1990
K946229 · BALANCE MANAGER
Download PDF FDA Summary Neurocom Internationa…