Cleared Traditional

K001166 - ULTRA V THERAPEUTIC ULTRASOUND

K001166 is an FDA 510(k) clearance for ULTRA V THERAPEUTIC ULTRASOUND, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K001166 · Excel Tech. , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
88d
Days
Class 2
Risk

K001166 is an FDA 510(k) clearance for the ULTRA V THERAPEUTIC ULTRASOUND. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on July 7, 2000 after a review of 88 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 Excel Tech. , Ltd. devices

FDA 510(k) Submission Details - K001166

510(k) Number K001166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date July 07, 2000
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 41
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K001166.
VECTORSONIC, MODEL VU-270
K030880 · Metron Medical Australia, Pty, Ltd. · Apr 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
K023050 · Reliant Technologies, Inc. · Feb 2003
VECTORSONIC, MODEL VU-200
K020119 · Metron Medical Australia, Pty, Ltd. · Jul 2002
VECTRA COMBO
K982317 · Chattanooga Group, Inc. · Feb 1999
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K982830 · Chattanooga Group, Inc. · Nov 1998
FORTE
K953614 · Chattanooga Group, Inc. · Oct 1995