The following data is part of a premarket notification filed by Caremed Supply, Inc. with the FDA for Vesoflow Lite Dvt Compression Device.
| Device ID | K181217 |
| 510k Number | K181217 |
| Device Name: | VesoFlow Lite DVT Compression Device |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Caremed Supply, Inc. 7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist. New Taipei City, TW 23145 |
| Contact | Tsung-hsuan Liu |
| Correspondent | Tsung-hsuan Liu Caremed Supply, Inc. 7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist. New Taipei City, TW 23145 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-08-05 |
| Summary: | summary |