The following data is part of a premarket notification filed by Foshan Hongfeng Co., Ltd with the FDA for Air Compression Therapy System Fo-3001; Air Compression Therapy System Fo-3008.
| Device ID | K201982 |
| 510k Number | K201982 |
| Device Name: | Air Compression Therapy System FO-3001; Air Compression Therapy System FO-3008 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Foshan Hongfeng Co., Ltd No.4-2 Leqiang Road, Leping Sanshui Foshan, CN 528000 |
| Contact | Cheng Dongfeng |
| Correspondent | Sam Lin Shanghai Spica Management Consulting Co., Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai, CN 201306 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-17 |
| Decision Date | 2021-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810113571949 | K201982 | 000 |
| 10810113571932 | K201982 | 000 |
| 10810113571925 | K201982 | 000 |
| 10810113572717 | K201982 | 000 |
| 10810113572700 | K201982 | 000 |
| 10810113572694 | K201982 | 000 |
| 10810113576975 | K201982 | 000 |
| 10810113576968 | K201982 | 000 |
| 10810113576951 | K201982 | 000 |