The following data is part of a premarket notification filed by Nuga Medical Co., Ltd with the FDA for Nm-7000.
| Device ID | K111329 |
| 510k Number | K111329 |
| Device Name: | NM-7000 |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | NUGA MEDICAL CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | JFB |
| Subsequent Product Code | ILY |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-09-06 |
| Summary: | summary |