510(k) · Cleared
ClearedTherasage Heating Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therasage Corporation · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 6, 2012 as substantially equivalent to K092589 (Eas Consulting Group, LLC, 2010) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Mar 6, 2012
- Review
- 39 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K072534 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K092589 | Thermotex Platinum SystemSummary page 2…Submission Predicate Devices: The Therasage Tm Heating Pad is substantially similar to the: Thermotex Heat Therapy Systems (K092589), as well as the RIO-MAT 2000 (K072534) - Rich Way International Inc. Technological Characteristics The Therasage~… | 2010 |
| * | K072534 | Bio-Mat 2000Summary page 2…redicate Devices: The Therasage Tm Heating Pad is substantially similar to the: Thermotex Heat Therapy Systems (K092589), as well as the RIO-MAT 2000 (K072534) - Rich Way International Inc. Technological Characteristics The Therasage~m Heating Pad is an electrically-powered heat… | 2008 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K092589.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Therasage Heating Pad is intended to provide topical heating to the user indicated for (a) the temporary relief of minor muscle and joint pain and stiffness; (b) the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and sprains, and minor muscular back pain; (c) muscular relaxation; and (d) the temporary increase of local circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120254 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120254: Therasage Heating Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120254
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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