K121718 is an FDA 510(k) clearance for the A-V FOOT PUMP. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Dalian Labtek Science & Development Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 17, 2012, 67 days after receiving the submission on June 11, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K121718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2012 |
| Decision Date | August 17, 2012 |
| Days to Decision | 67 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 |