Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007028037

FEI Number

3007028037

Entity Name

RITM OKB ZAO

City/State/Country

TAGANROG Rostovskaya Oblast', RU

Establishment Address

99, PETROVSKAYA, TAGANROG Rostovskaya Oblast' 347900, RU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RITM OKB ZAO (Owner Number: 9096120)

Owner / Operator Contact Address

99, PETROVSKAYA, --, TAGANROG, RU-ROS 347900, RU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131513

PMA Number

N/A

All Registered Proprietary Names

SCENAR® Tennant BioModulator® Pro Elite SCENAR SCENAR® FORCE SCENAR® Tennant BioModulator® Plus Advantage SCELAP SCENAR SCELAP SCENAR SCELAP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2010-10-07
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2006-12-29
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-12-04
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2014-12-04

Official Correspondent

Dmitry Khlaponin

US Agent Details

Vladimir Goncharov Email: Vladimir.tx@gmail.com Phone: (989) 2723627

Related Public Records

Same Entity

RITM OKB ZAO

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007028037. Last updated year: 2026. Please use registration number 3007028037 when referencing this establishment in official correspondence.