K111329 is an FDA 510(k) clearance for the NM-7000. This device is classified as a Table, Physical Therapy, Multi Function (Class II - Special Controls, product code JFB).
Submitted by Nuga Medical Co., Ltd. (Echo, US). The FDA issued a Cleared decision on September 6, 2011, 118 days after receiving the submission on May 11, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5880.
| 510(k) Number | K111329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2011 |
| Decision Date | September 06, 2011 |
| Days to Decision | 118 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 |