The following data is part of a premarket notification filed by Maxstar Industrial Co., Ltd with the FDA for Air Relax.
| Device ID | K173158 |
| 510k Number | K173158 |
| Device Name: | Air Relax |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Maxstar Industrial Co., Ltd 152 - 12 Hwanggeum-ro 23beon-gil, Yangchon-eup Gimpo, KR 415843 |
| Contact | Lee Bunghyun |
| Correspondent | Chris Park Med.com 1809 Holland Dr Somerset, NJ 08873 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2019-05-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AIR RELAX 86931510 5063289 Live/Registered |
Diode Art Engineering Inc 2016-03-07 |