510(k) · Cleared
ClearedSW-180 Shortwave Therapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Jan 28, 2003 as substantially equivalent to K973732 (Pti, 1998) after a 154-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 28, 2003
- Review
- 154 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973732 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK973732 Megapulse IIPti · 1998
- This deviceK022846 SW-180 Shortwave Therapy UnitIto Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973732 | Megapulse II | Pti | 1998 | — |
| 0 (this device) | K022846 | SW-180 Shortwave Therapy Unit | Ito Co., Ltd. | 2003 | — |
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 |
|---|---|---|---|
| * | K973732 | Megapulse IISummary page 1…repared: August 26, 2002 A. LEGALLY MARKETED PREDICATE DEVICES The SW-180 Shortwave Therapy Unit is substantially equivalent to the Megapulse It (K973732) manufactured by Electro-Medical, Ltd. 6. DEVICE DESCRIPTION The SW-I80 Shortwave Therapy Unit consists of a main… | 1998 |
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.
- 1 other device also cites its predicate K973732.
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 SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022846: SW-180 Shortwave Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022846
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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