The following data is part of a premarket notification filed by Weero Co. with the FDA for Apollo Duet (model : Apd-4000).
| Device ID | K212253 |
| 510k Number | K212253 |
| Device Name: | Apollo Duet (Model : APD-4000) |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Weero Co. A605 Venture Valley II, 142-10, Saneop-ro 156 Beon-gil Gwonseon-gu Suwon-si, KR 16648 |
| Contact | Jimin Han |
| Correspondent | Eunice Cho Weero Co. A605 Venture Valley II, 142-10, Saneop-ro 156 Beon-gil Gwonseon-gu Suwon-si, KR 16648 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-19 |
| Decision Date | 2022-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809851470015 | K212253 | 000 |