510(k) · Cleared
ClearedUltratherm (908)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sie-Med, Inc. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Apr 3, 1997 as substantially equivalent to K862589 (Elmed, Inc., 1986) after a 174-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 3, 1997
- Review
- 174 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862589 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK862589 Ultratherm 808 IElmed, Inc. · 1986
- This deviceK964083 Ultratherm (908)Sie-Med, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862589 | Ultratherm 808 I | Elmed, Inc. | 1986 | — |
| 0 (this device) | K964083 | Ultratherm (908) | Sie-Med, Inc. | 1997 | — |
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 IMJ? 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 IMJ device
- #1 K252963 BTL-899TTscore 12.4 · 4 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 |
|---|---|---|---|
| * | K862589 | Ultratherm 808 ISummary page 1…for 4 to 5 years and in Canada for 1 year. The same firm also manufactures the Ultratherm 808i which the present applicant distri- butes under a premarket notification (K862589) cleared by FDA on August 1, 1986. The safety, effectiveness, and reliability of the Ultratherm 9081 have been established by the… | 1986 |
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.
How does its category compare?
All IMJ devicesIMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMJ
131in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMJ
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMJ
1in 2019
MAUDE reports naming product code IMJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 3 | 393 | 0 | 3 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 3 | 131 | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ultratherm 9081 is a shortwave diathermy device mtended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
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/K964083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964083: Ultratherm (908).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964083
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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