The following data is part of a premarket notification filed by Nuga Medical Co., Ltd with the FDA for N5-1.
| Device ID | K153054 |
| 510k Number | K153054 |
| Device Name: | N5-1 |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | NUGA MEDICAL CO., LTD 185, JIRAEUL-RO, JIJEONG-MYEON Wonju, KR 220-821 |
| Contact | Jong Soo Lee |
| Correspondent | Jong Soo Lee NUGA MEDICAL CO., LTD 185, JIRAEUL-RO, JIJEONG-MYEON Wonju, KR 220-821 |
| 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 | No |
| Combination Product | No |
| Date Received | 2015-10-20 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800091150132 | K153054 | 000 |