Cleared Traditional

SPINETRAK (K890074) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890074 · Motion Analysis Corp. · Physical Medicine device
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Feb 1989
Decision
25d
Days
Class 2
Risk

K890074 is an FDA 510(k) clearance for the SPINETRAK. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Motion Analysis Corp. (Santa Rosa, US). The FDA issued a Cleared decision on February 3, 1989 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 890.5360 - 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.

View all Motion Analysis Corp. devices

Submission Details

510(k) Number K890074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1989
Decision Date February 03, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXJ Interactive Rehabilitation Exercise Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - LXJ Interactive Rehabilitation Exercise Devices

All 26
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K890074.
VERA
K192474 · Reflexion Health, Inc. · Oct 2019
Vera
K182333 · Reflexion Health, Inc. · Apr 2019
DARI Health
K180880 · Scientific Analytics, Inc. · Mar 2019
Qualisys Clinical System
K171547 · Qualisys AB · Aug 2018
MindMotion(TM) GO
K173931 · Mindmaze SA · May 2018
UINCARE HOME
K172882 · Uincare Corp. · May 2018