The following data is part of a premarket notification filed by Shenzhen Dongjilian Electronics Co.,ltd. with the FDA for Air Compression Therapy Device.
| Device ID | K193354 |
| 510k Number | K193354 |
| Device Name: | Air Compression Therapy Device |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Shenzhen Dongjilian Electronics Co.,Ltd. B1/1-5F, Tonglu Industrial Area, Tongxin Community Longgang District Shenzhen, CN 518116 |
| Contact | Zhang Hong |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518105 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-06-08 |