The following data is part of a premarket notification filed by 4l Health Co., Ltd. with the FDA for Foryou Npwt Dressing Kit.
| Device ID | K190119 |
| 510k Number | K190119 |
| Device Name: | Foryou NPWT Dressing Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | 4L Health Co., Ltd. No. 108, Dongxin Rd, DongJiang Hi-tech Dist. Huizhou, CN 516000 |
| Contact | Jackie Jian |
| Correspondent | Jackie Jian 4L Health Co., Ltd. No. 108, Dongxin Rd, DongJiang Hi-tech Dist. Huizhou, CN 516000 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-24 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970076370113 | K190119 | 000 |
| 06970076370076 | K190119 | 000 |
| 06970076370069 | K190119 | 000 |
| 06970076370052 | K190119 | 000 |