510(k) · Cleared
ClearedSoftique, Model GI 11001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global TV Concepts, Ltd. · IMC Bath, Paraffin
Cleared on Feb 1, 2002 as substantially equivalent to K001860 (Homedics, Inc., 2000) after an 85-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 1, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- IMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001860 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001860 Paraspa Paraffin Bath, Paraspap Mini, Paraspa UltraHomedics, Inc. · 2000
- This deviceK013707 Softique, Model GI 11001Global TV Concepts, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001860 | Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra | Homedics, Inc. | 2000 | — |
| 0 (this device) | K013707 | Softique, Model GI 11001 | Global TV Concepts, Ltd. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001860 | Paraspa Paraffin Bath, Paraspap Mini, Paraspa UltraSummary page 2…araffin Bath is substantially equivalent to the following models of paraffin baths currently in commercial distribution: 1. ParaSpa™ (PAR-200) Paraffin Bath by Homedics K001860 2. Therabath® by W.R. Medical Electronics Co. pre-amendment device Technological Characteristics Substantial equivalence is cla… | 2000 |
| * | — | Therabath® Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K001860.
How does its category compare?
All IMC devicesIMC Bath, Paraffin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMC
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · IMC
Too few IMC 510(k)s in any year since 2007 to give a median.
Recalls per year · IMC
No recall names IMC since 2007.
Adverse event reports per year · IMC
4in 2025
MAUDE reports naming product code IMC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013707: Softique, Model GI 11001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013707
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026