K123830 is an FDA 510(k) clearance for the INTERMITTENT PNEUMATIC COMPRESSION DEVICE. 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 16, 2013, 247 days after receiving the submission on December 12, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K123830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2012 |
| Decision Date | August 16, 2013 |
| Days to Decision | 247 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 |