The following data is part of a premarket notification filed by Ritm Okb Zao with the FDA for Scenar (scelap, Enisar, Ipens) Cutaneous Electrode Family.
| Device ID | K131513 |
| 510k Number | K131513 |
| Device Name: | SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | RITM OKB ZAO 99, PETROVSKAYA Taganrog, RU 347900 |
| Contact | Larisa Shpungina |
| Correspondent | Larisa Shpungina RITM OKB ZAO 99, PETROVSKAYA Taganrog, RU 347900 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2014-07-11 |
| Summary: | summary |