aria-therapy.comAria System
Inova Labs
INOVA LABS INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016721280 | 3016721280 | INOVA LABS INC. | 1 | N | 2020-04-25 | 7581 Convoy Court San Diego CA US 92111 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860003034712 | Aria Free™ - Aria Free, large | (866) 647 0691 | support@aria-therapy.com |
| 00860003034729 | Aria Free™ - Aria Free, medium | (866) 647 0691 | support@aria-therapy.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 252557 | 1270415728 | K200564 | Aria System | JOW | 2020-04-03 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JOW | 1 | 2020-04-03 |
PMN#
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
INOVA LABS, INC.
LIFECHOICE OXYGEN CONCENTRATOR
INOVA LABS, INC.
GUDID#
Aria Free™ - Aria Free, small
2020-10-27
Aria Free™ - Aria Free, medium
2020-10-27
Aria Free™ - Aria Free, large
2020-10-27
Aria Free™ - Aria Free, connector tube
2021-01-15
Aria Free™ - Companion Bag - Standard
2021-03-24
MOBI AMER1 - The ResMed MOBI is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institutional or travel environment. The MOBI is also portable.
2018-04-26
Lifechoice Activox P4L - The current LifeChoice Activox Portable Oxygen Concentrator (Generator) is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator provides supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice Activox is also portable.
2016-08-17
Lifechoice Activox P4L - The current LifeChoice Activox Portable Oxygen Concentrator (Generator) is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator provides supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice Activox is also portable.
2016-08-17
Lifechoice Activox P4L - The current LifeChoice Activox Portable Oxygen Concentrator (Generator) is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen.The oxygen concentrator provides supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institution or travel environment.The LifeChoice Activox is also portable.
2016-08-17
Lifechoice Activox P4L - The current LifeChoice Activox Portable Oxygen Concentrator (Generator) is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen.The oxygen concentrator provides supplemental, high concentration oxygen to these patients. It is not life-supporting nor life-sustaining. It may be used continuously in a home, institution or travel environment.The LifeChoice Activox is also portable.
2016-08-17