The following data is part of a premarket notification filed by Medirune Co, Ltd with the FDA for I Rune (i-200l).
| Device ID | K122410 |
| 510k Number | K122410 |
| Device Name: | I RUNE (I-200L) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | MEDIRUNE CO, LTD 821 SAMIL PLAZA 837-26 YEUKSAM-DONG Gangnam-gu, KR 135-768 |
| Contact | Yang Ho Dong |
| Correspondent | Yang Ho Dong MEDIRUNE CO, LTD 821 SAMIL PLAZA 837-26 YEUKSAM-DONG Gangnam-gu, KR 135-768 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-11-12 |
| Summary: | summary |