Cleared Traditional

K940200 - EXCEL TX

K940200 is an FDA 510(k) clearance for EXCEL TX, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K940200 · Excel Tech. , Ltd. · Physical Medicine device
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Jun 1994
Decision
145d
Days
Class 2
Risk

K940200 is an FDA 510(k) clearance for the EXCEL TX. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on June 7, 1994 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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.

View all Excel Tech. , Ltd. devices

FDA 510(k) Submission Details - K940200

510(k) Number K940200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1994
Decision Date June 07, 1994
Days to Decision 145 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 115d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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.