510(k) · Cleared
ClearedMegapulse II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pti · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Jan 23, 1998 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 63 later devices descend from it.
- Decided
- Jan 23, 1998
- Review
- 115 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 2 citing it directly.
- This deviceK973732 Megapulse IIPti · 1998
- Descendant · cites it directly · 61 of its ownK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009 · Recalled
- Descendant · 2 generations on · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · 3 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 4 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 3 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group · 2009 · cites it directly61descendants
- K090221Reaction SystemViora, Ltd. · 2009 · 2 generations on54descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 3 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 4 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973732 | Megapulse II | Pti | 1998 | — |
| +1 | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group | 2009 | 1 |
| +2 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +3 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +4 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (63)
See all 632 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?
- Of its descendants, K083433 (Chattanooga Group, 2009) has gone furthest, with 61 descendants of its own.
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?
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:
1. Increases the extensibility of collagen tissues
Decreases joint stiffness
Relieves pain
Relieves muscle spasm
Increases blood flow
The Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:
1. Disorders of the musculoskeletal system:
muscle spasm
joint stiffness, contractures
2. Chronic inflammatory or infective conditions:
tenosynovitis, bursitis, synovitis
chronic inflammatory pelvic diseases
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973732: Megapulse II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973732
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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