The following data is part of a premarket notification filed by Winix Inc. with the FDA for Qorda Qd1.
| Device ID | K220990 |
| 510k Number | K220990 |
| Device Name: | Qorda QD1 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | Winix Inc. 80-13, Sujeong-ro, Jangan-myeon Hwaseong-si, KR 18583 |
| Contact | Daewoon Kang |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-09-14 |