The following data is part of a premarket notification filed by Maxstar Industrial Co., Ltd. with the FDA for Air Relax, Compressible Limb Sleeve System (model: Ar-1.0, Ar-2.0).
| Device ID | K191441 |
| 510k Number | K191441 |
| Device Name: | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Maxstar Industrial Co., Ltd. 152 - 12 Hwanggeum-ro 23beon-gil, Yangchon-eup Gimpo, KR 415843 |
| Contact | Jonghwa Lim |
| Correspondent | Chris Park Med.com 1809 Holland Dr Somerset, NJ 08873 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-30 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809040526844 | K191441 | 000 |
| 08809040526837 | K191441 | 000 |
| 08809040526820 | K191441 | 000 |
| 08809040526813 | K191441 | 000 |
| 08809040527032 | K191441 | 000 |
| 08809040527025 | K191441 | 000 |
| 08809040527018 | K191441 | 000 |