The following data is part of a premarket notification filed by Shenzhen Dongjilian Medical Tech Co., Ltd. with the FDA for Air Compression Leg Massager (models: S9036c, S9036b And S9036a).
| Device ID | K222206 |
| 510k Number | K222206 |
| Device Name: | Air Compression Leg Massager (Models: S9036C, S9036B And S9036A) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Shenzhen Dongjilian Medical Tech Co., Ltd. B1/15F, 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 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-09-30 |