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 |