# K003916: Dermalife Hydrofusion Skin & Body Care System

- Pathway: 510(k) (Traditional)
- Applicant: Scandia Manufacturing, Ltd.
- Decided: Apr 15, 2002 after 482 days
- Product code: IMB (Cabinet, Moist Steam)
- Device class: 2
- Regulation: 21 CFR 890.5250
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 22, 2007 · Not classified · Z-1605-2009: 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, S
- Jun 22, 2007 · Not classified · Z-1602-2009: 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, S
- Jun 22, 2007 · Not classified · Z-1603-2009: 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, S
- Jun 22, 2007 · Not classified · Z-1604-2009: 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, S
- May 15, 2007 · Not classified · Z-1245-2009: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K003916
Methodology: https://510kreport.com/methodology