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 Plus Model Ar-3.0.
| Device ID | K211460 |
| 510k Number | K211460 |
| Device Name: | Air Relax Plus Model AR-3.0 |
| 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 | 2021-05-11 |
| Decision Date | 2021-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809040526400 | K211460 | 000 |
| 08809040526288 | K211460 | 000 |
| 08809040526295 | K211460 | 000 |
| 08809040526301 | K211460 | 000 |
| 08809040526318 | K211460 | 000 |
| 08809040526325 | K211460 | 000 |
| 08809040526332 | K211460 | 000 |
| 08809040526349 | K211460 | 000 |
| 08809040526356 | K211460 | 000 |
| 08809040526363 | K211460 | 000 |
| 08809040526370 | K211460 | 000 |
| 08809040526387 | K211460 | 000 |
| 08809040526394 | K211460 | 000 |
| 08809040526271 | K211460 | 000 |