Cleared Traditional

VECTRA COMBO

K982317 · Chattanooga Group, Inc. · Physical Medicine

Feb 1999

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K982317 is an FDA 510(k) clearance for the VECTRA COMBO, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on February 1, 1999, 214 days after receiving the submission on July 2, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K982317 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 1998
Decision Date	February 01, 1999
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

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