510(k) · Cleared
Recalled · Class II · 2015Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Mar 18, 2009 as substantially equivalent to K042554 (Mettler Electronics Corp., 2004) and 3 other predicates after a 118-day review. Its family tree reaches back 2 generations to 1986. 61 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2009
- Review
- 118 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K861248 (1986). 5 ancestors in all. 61 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK861248 Curapuls 419 Diathermy UnitHenley Intl. · 1986
- 1 generation backK022458 Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002
- This deviceK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009
- Descendant · cites it directly · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 2 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 3 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K090221Reaction SystemViora, Ltd. · 2009 · cites it directly54descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 3 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 2 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861248 | Curapuls 419 Diathermy Unit | Henley Intl. | 1986 | — |
| −1 | K022458 | Auto*Therm 395, Model ME 395 | Mettler Electronics Corp. | 2002 | — |
| 0 (this device) | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group | 2009 | — |
| +1 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +3 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 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? (4)
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 3…ufacture's Classification Numbers and Product Names Codes K042554 Auto Therm 390 Mettler Electroinics, Shortwave 890.5290 Class II, IMJ… | 2004 |
| * | K030382 | Selitherm, Model C100Summary page 3…2554 Auto Therm 390 Mettler Electroinics, Shortwave 890.5290 Class II, IMJ Corporation Diathermy K030382 SeliTherm Selicor, Inc. Shortwave 890.5290 Class II, IMJ… | 2003 |
| * | K022458 | Auto*Therm 395, Model ME 395Summary page 3…382 SeliTherm Selicor, Inc. Shortwave 890.5290 Class II, IMJ Diathermy K022458 Auto Therm 395 Mettler Electronics, Shortwave 890.5290 Class II, IMJ… | 2002 |
| * | K973732 | Megapulse IISummary page 3…458 Auto Therm 395 Mettler Electronics, Shortwave 890.5290 Class II, IMJ Corporation Diathermy K973732 Megapulse II PTI, Inc. Shortwave 890.5290 Class II, IMJ… | 1998 |
What descends from it? (61)
See all 614 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2015 | Class II | Z-0121-2016 | Device Design | Overheating and burning of the wire insulation inside the applicator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090221 (Viora, Ltd., 2009) has gone furthest, with 54 descendants of its own.
- 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. 2009, 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?
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
Pain Relief
Reduce Muscle Spasm
Decrease Joint Stiffness
Contractures
Iincrease Blood Flow
Chronic Inflammatory Conditions
Bursitis
Tenosynovitis
Synovitis
Chronic Inflammatory Pelvic Disease
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083433
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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