K213313 is an FDA 510(k) clearance for the Veinoflow SCD (Model: LBTK-M-I 5006). This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Dalian Labtek Science & Development Co., Ltd. (Dalian, CN). The FDA issued a Cleared decision on February 9, 2022, 128 days after receiving the submission on October 4, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K213313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2021 |
| Decision Date | February 09, 2022 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |