# K013707: Softique, Model GI 11001

- Pathway: 510(k) (Traditional)
- Applicant: Global TV Concepts, Ltd.
- Decided: Feb 1, 2002 after 85 days
- Product code: IMC (Bath, Paraffin)
- Device class: 2
- Regulation: 21 CFR 890.5110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001860 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001860: Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra, Homedics, Inc. (2000) Summary page 2.
- (no number) Therabath®: named in the summary without a submission number

## Indications for use
1. Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation 2. Relaxes muscles, relieves stiffness and muscle spasm 3. Stimulates circulation and for other conditions where heat is indicated

Source page: https://510kreport.com/device/K013707
Methodology: https://510kreport.com/methodology