Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010770433

FEI Number

3010770433

Entity Name

EBULENT OPTRONICS (SHENZHEN) LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Block901, Floor9, Building 1, Senyang Electronics Technologies Park, Guangming District, Shenzhen, Guangdong, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ebulent Optronics (Shenzhen) LTD (Owner Number: 10061444)

Owner / Operator Contact Address

Block A&B, Floor 9, Building 1, Senyang Electronics Technologies Park, Guangming District, Shenzhen, Guangdong, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compex Edge 3 Compex Performance 3 Compex Sport Elite 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2020-12-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-12-01
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-12-01

Official Correspondent

Tony xu

US Agent Details

Xiao-Yang Huang Email: xhuang@ebulent.com Phone: (330) 2563357

Related Public Records

Same Entity

Ebulent Optronics (Shenzhen) LTD

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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010770433. Last updated year: 2026. Please use registration number 3010770433 when referencing this establishment in official correspondence.