The following data is part of a premarket notification filed by Diode Art Engineering Doing Business As Air Relax with the FDA for Air Relax Pro Model Ar-4.0.
| Device ID | K212491 |
| 510k Number | K212491 |
| Device Name: | Air Relax Pro Model AR-4.0 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Diode Art Engineering Doing Business As Air Relax 9535 Brasher St Pico Rivera, CA 90660 |
| Contact | Beomjoon Lee |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809040526585 | K212491 | 000 |
| 08809040526479 | K212491 | 000 |
| 08809040526486 | K212491 | 000 |
| 08809040526493 | K212491 | 000 |
| 08809040526509 | K212491 | 000 |
| 08809040526516 | K212491 | 000 |
| 08809040526523 | K212491 | 000 |
| 08809040526530 | K212491 | 000 |
| 08809040526547 | K212491 | 000 |
| 08809040526554 | K212491 | 000 |
| 08809040526561 | K212491 | 000 |
| 08809040526578 | K212491 | 000 |
| 08809040526462 | K212491 | 000 |