The following data is part of a premarket notification filed by Dalian Labtek Science & Development Co., Ltd. with the FDA for Veinoflow Scd (model: Lbtk-m-i 5006).
| Device ID | K213313 |
| 510k Number | K213313 |
| Device Name: | Veinoflow SCD (Model: LBTK-M-I 5006) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Dalian Labtek Science & Development Co., Ltd. 1-18-17, Liandong Street, Advanced Equipment Manufacturing Industry Park Economic-Technologic Dalian, CN 116085 |
| Contact | Yao Cui |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2022-02-09 |