510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013707Substantially Equivalent

Softique, Model Gi 11001

Global TV Concepts, Ltd., Deerfield Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013707 is the FDA 510(k) clearance record for SOFTIQUE, MODEL GI 11001, a class II device, cleared for Global TV Concepts, Ltd. on under FDA product code IMC (Bath, Paraffin). FDA records list 3 510(k) clearances for Global TV Concepts, Ltd., from to . As of , FDA records show no recalls naming K013707.

Clearance record

Decision date
Received
(85 days to decision)
Product code
IMC Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Applicant
Global TV Concepts, Ltd. 676 S. Military Trl., Deerfield Beach FL
510(k) summary
Summary
Third party review
No

Clearances, product code IMC

Trailing 12 months

FDA records hold no clearances under product code IMC in the trailing twelve months.

FDA records show no clearances under product code IMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260