Cleared Traditional

K945954 - MODELS 4100 AND 4300 MULTITHERAPY

K945954 is the FDA 510(k) clearance for MODELS 4100 AND 4300 MULTITHERAPY by Spinalight, Inc.. It is a Class 2 Physical Medicine device (product code JFB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K945954 · Spinalight, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
44d
Days
Class 2
Risk

K945954 is an FDA 510(k) clearance for the MODELS 4100 AND 4300 MULTITHERAPY. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Spinalight, Inc. (Woodstock, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Spinalight, Inc. devices

Submission Details

510(k) Number K945954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1994
Decision Date January 19, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
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 - JFB Table, Physical Therapy, Multi Function

All 13
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