Devices

Device Recall Rejuv 02 Oxygen Spa.

Model / Serial
All units are under recall.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Units were sent to 2 direct distributors located in GA.
Product Description
Rejuv O2 Home Oxygen Spa ¿ 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.
Manufacturer
System 02 Inc
1 Event
- Recall of Device Recall Rejuv 02 Oxygen Spa.

Manufacturer

System 02 Inc

Manufacturer Address
System 02 Inc, 1090 Upper Hembree Rd, Roswell GA 300761140
Source
USFDA

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