510(k) · Cleared
ClearedThermotex Platinum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eas Consulting Group, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 28, 2010 as substantially equivalent to K072534 (Richway Intl., Inc., 2008) after a 157-day review. Its family tree reaches back 1 generation to 2008. 4 later devices descend from it.
- Decided
- Jan 28, 2010
- Review
- 157 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072534 (2008). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK072534 Bio-Mat 2000Richway Intl., Inc. · 2008
- This deviceK092589 Thermotex Platinum SystemEas Consulting Group, LLC · 2010
- Descendant · cites it directly · 1 of its ownK111273 Fir Heat Theraphy SysyemsShenzhen Anpan Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK133981 Avacen 100Avacen, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120254 Therasage Heating PadTherasage Corporation · 2012
- Descendant · cites it directly · 0 of its ownK101227 Back-TekYork Biomedical, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K111273Fir Heat Theraphy SysyemsShenzhen Anpan Technology Co., Ltd. · 2011 · cites it directly1descendant
- K133981Avacen 100Avacen, Inc. · 2014 · 2 generations on0descendants
- K120254Therasage Heating PadTherasage Corporation · 2012 · cites it directly0descendants
- K101227Back-TekYork Biomedical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072534 | Bio-Mat 2000 | Richway Intl., Inc. | 2008 | — |
| 0 (this device) | K092589 | Thermotex Platinum System | Eas Consulting Group, LLC | 2010 | — |
| +1 | K111273 | Fir Heat Theraphy Sysyems | Shenzhen Anpan Technology Co., Ltd. | 2011 | — |
| +2 | K133981 | Avacen 100 | Avacen, Inc. | 2014 | — |
| +1 | K120254 | Therasage Heating Pad | Therasage Corporation | 2012 | — |
| +1 | K101227 | Back-Tek | York Biomedical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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 ILY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K072534 | Bio-Mat 2000Summary page 1…tion; and the temporary increase of local circulation where applied. Predicate Devices: The Thermnotex Heat Therapy Systems is substantially equivalent to BIO-MAT 2000 (K072534) - Rich Way International Inc. Technological Characteristics The Thermnotex Heat Therapy Systems are electrically-powered pads t… | 2008 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092589: Thermotex Platinum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092589
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026