K153054 is an FDA 510(k) clearance for the N5-1. This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Nuga Medical Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on February 5, 2016, 108 days after receiving the submission on October 20, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K153054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2015 |
| Decision Date | February 05, 2016 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | JFB - Table, Physical Therapy, Multi Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5880 |