510(k) · Cleared
ClearedProMedTek Model C1400 Shortwave Diathermy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedtek, Inc. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 17, 2016 as substantially equivalent to K042554 (Mettler Electronics Corp., 2004) after a 100-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 17, 2016
- Review
- 100 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042554 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042554 Auto Therm 390, Model ME 390Mettler Electronics Corp. · 2004
- This deviceK162240 ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042554 | Auto Therm 390, Model ME 390 | Mettler Electronics Corp. | 2004 | — |
| 0 (this device) | K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K042554 | Auto Therm 390, Model ME 390Summary page 4…IMJ Panel: Physical Medicine 3. PREDICATE DEVICE The predicate device is Auto Therm 390, Model ME 390 (Mettler Electronics Corp., K042554). 1 4. DESCRIPTION OF THE DEVICE The ProMedTek C1400 shortw… | 2004 |
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.
- 2 other devices also cite its predicate K042554.
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. 2016, this device’s year, is highlighted.
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 ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
1. Relieving pain
2. Reducing muscle spasm
3. Increasing range of motion of contracted joints using heat and stretch techniques
4. Increasing blood flow to tissues in the treatment area
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162240: ProMedTek Model C1400 Shortwave Diathermy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162240
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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