Cleared Traditional

VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS) (K040285) - FDA 510(k) Clearance

Also marketed or referenced as:
INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER

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

K040285 · Chattanooga Group · Physical Medicine device
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Apr 2004
Decision
66d
Days
Class 2
Risk

K040285 is an FDA 510(k) clearance for the VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS). Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on April 12, 2004 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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 Chattanooga Group devices

Submission Details

510(k) Number K040285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date April 12, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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.