510(k) · Cleared
Recalled · 2007Dermalife Hydrofusion Skin & Body Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandia Manufacturing, Ltd. · IMB Cabinet, Moist Steam
Cleared on Apr 15, 2002 after a 482-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 5 times.
- Decided
- Apr 15, 2002
- Review
- 482 days
- Class
- Class II
- Product code
- IMB
- Recalls
- 5
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 IMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2007 | Not classified | Z-1605-2009 | Device Design | A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan… |
| Jun 22, 2007 | Not classified | Z-1602-2009 | Device Design | A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan… |
| Jun 22, 2007 | Not classified | Z-1603-2009 | Device Design | A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan… |
| Jun 22, 2007 | Not classified | Z-1604-2009 | Device Design | A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan… |
| May 15, 2007 | Not classified | Z-1245-2009 | Device Design | Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All IMB devicesIMB Cabinet, Moist Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMB
FDA has decided no IMB device since 2007.
Median 510(k) review, days · IMB
Too few IMB 510(k)s in any year since 2007 to give a median.
Recalls per year · IMB
5in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMB
2in 2009
MAUDE reports naming product code IMB, 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 | — | 5 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. To temporarily increase local blood circulation.
2. To temporarily reduce minor muscular pain.
3. To help induce relaxation of muscles.
4. To treat arthritis and fibrosis.
5. To provide topical heating.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K003916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003916: Dermalife Hydrofusion Skin & Body Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026