The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Venen-trainer (model: Fm150, Sfm90).
| Device ID | K203746 |
| 510k Number | K203746 |
| Device Name: | Venen-trainer (Model: FM150, SFM90) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Shenzhen Pango Electronic CO., LTD No.25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang Distict Shenzhen, CN 518115 |
| Contact | Guojun Zeng |
| Correspondent | Cassie Lee Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-22 |
| Decision Date | 2021-11-10 |