RGS

The RGS is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS have…

Registry build 21.09.26

The RGS is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS have demonstrated the ability to deactivate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.

2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code FRA
Manufacturer City Province Registered as Device types
Guangzhou Ajax Medical Equipment Co Ltd Guangzhou Guangdong Manufacturer 13
Shenzhen Airgle Corporation Limited Shenzhen Guangdong Manufacturer 4

Record

Regulatory record for RGS
Listed by Genesis AIR, Inc., United States
FDA product code FRA
Device type Purifier, Air, Ultraviolet, Medical
Device class Class 2
Regulation 21 CFR 880.6500
Establishment Manufacturer
510(k) K222702
Record published 2023-07-18

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for RGS
Catalogue number Size Status
RGS In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Airgle Airgle Corporation 10
RGF-BioControls RGF Environmental Group, Inc 9
Aerobiotix Aerobiotix USA 5
ADS Guangzhou Ajax Medical Equipment Co Ltd 5
Molekule Air Mini + Molekule Group, Inc. 2
Molekule Molekule Group, Inc. 1
The Pyure Company The Pyure Company Inc 1
ActivePure Medical Guardian Activepure Medical LLC 1
Purgo Molekule Group, Inc. 1
RGS mini Genesis AIR, Inc. 1
Medical Guardian Aerus Medical, LLC 1
Molekule Air Pro Molekule Group, Inc. 1

Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K222702 2023-06-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer