Data / Medical devices / Russia / Ritm Okb Zao
Ritm Okb Zao: FDA-registered device maker in TAGANROG Rostovskaya Oblast', Russia, 2 510(k) clearances
Ritm Okb Zao is registered with the FDA (registration 3007028037) in TAGANROG Rostovskaya Oblast', Russia. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 11, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007028037
- Address
- 99, Petrovskaya, TAGANROG Rostovskaya Oblast', Russia, 347900
- Owner or operator
- RITM OKB ZAO (9096120)
- Roles
- Manufacturer
- First device listed
- December 29, 2006
- Registered through
- 2026
- Brand names listed
- SCELAP, SCENAR, SCENAR® FORCE, SCENAR® Tennant BioModulator® Plus Advantage, SCENAR® Tennant BioModulator® Pro Elite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2014 | K131513 | SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY | GZJ | Substantially Equivalent | Ritm Okb Zao | accessdata.fda.gov |
| May 28, 2010 | K092117 | SCENAR, MODEL 10 | GZJ | Substantially Equivalent | Ritm Okb Zao | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Electrode, Cutaneous
- All makers of Device, Biofeedback
Updated July 11, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.