510(k) · Cleared
ClearedDermawave 5000 Combi Max System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermawave, LLC · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Mar 17, 2004 as substantially equivalent to K982317 (Chattanooga Group, Inc., 1999) and 3 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Mar 17, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K923076 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923076 | Ultra SX | Excel Tech., Ltd. | 1993 | — |
| −1 | K001166 | Ultra V Therapeutic Ultrasound | Excel Tech., Ltd. | 2000 | — |
| 0 (this device) | K040121 | Dermawave 5000 Combi Max System | Dermawave, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 2 | 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 IMG? 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 IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K982317 | Vectra ComboSummary page 1…FR 882. 5890 LIH Interferential Current Therapy 21 CFR 890.5500 ILY Class 2 Infrared Lamp 3. Predicate Devices * Chatanooga Group Inrc., Vectra 2C & Vectra 4C (K982317) * Chaatanooga Group Inc. Vectra Pro 2 & Vectra Pro 4 (K982324) * Dynatronics Corporation, Dynatron 150 Plus Ultrasound (… | 1999 |
| * | K982324 | Vectra Pro Models 2 and 4Summary page 1…LY Class 2 Infrared Lamp 3. Predicate Devices * Chatanooga Group Inrc., Vectra 2C & Vectra 4C (K982317) * Chaatanooga Group Inc. Vectra Pro 2 & Vectra Pro 4 (K982324) * Dynatronics Corporation, Dynatron 150 Plus Ultrasound (K935728) * Excel Tech, XL Tek 'Ultra VM Ultrasound (KOO1 166)… | 1999 |
| * | K935728 | Dynatron 150Summary page 1…up Inrc., Vectra 2C & Vectra 4C (K982317) * Chaatanooga Group Inc. Vectra Pro 2 & Vectra Pro 4 (K982324) * Dynatronics Corporation, Dynatron 150 Plus Ultrasound (K935728) * Excel Tech, XL Tek 'Ultra VM Ultrasound (KOO1 166) * MedX 1000 Console (K020017) · MedX LCT 100 Laser Accessory (K… | 1994 |
| * | K001166 | Ultra V Therapeutic Ultrasound | 2000 |
| † | K020017 | Medx 1000 Series | 2002 |
| † | K032231 | MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser | 2003 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K982317.
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, 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 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine. The indications of the DermaWave…
Read the full statement (247 words)
Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine.
The indications of the DermaWave 5000 Combi Max System also include the treatment and relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate post-surgical stimulation of calf rauscles to prevent venous thrombosis, symptomatic relief of chronic intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected medical conditions such as relief of pain, muscle spasms and joint contractures, relief of pain muscle spasms and joint contractures that may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of chronic and sub-chronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound.
The DermaWave 5000 Combi Max System is also indicated for use in providing topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040121: Dermawave 5000 Combi Max System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040121
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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