Cleared Traditional

K013707 - SOFTIQUE, MODEL GI 11001
(FDA 510(k) Clearance)

K013707 · Global TV Concepts, Ltd. · Physical Medicine

Feb 2002

Decision

85d

Days

Class 2

Risk

K013707 is an FDA 510(k) clearance for the SOFTIQUE, MODEL GI 11001. This device is classified as a Bath, Paraffin (Class II — Special Controls, product code IMC).

Submitted by Global TV Concepts, Ltd. (Deerfield Beach, US). The FDA issued a Cleared decision on February 1, 2002, 85 days after receiving the submission on November 8, 2001.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number	K013707 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2001
Decision Date	February 01, 2002
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF