Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027062656

FEI Number

3027062656

Entity Name

SHENZHEN YIRAN INTELLIGENT CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 6, No. 531 Nanpu Road, Huangpu Community, Xinqiao Street, Bao'an District,, Shenzhen Guangdong 518125, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Yiran Intelligent Co., Ltd (Owner Number: 10087619)

Owner / Operator Contact Address

Floor 6, No. 531 Nanpu Road, Huangpu Community, Xinqiao Street, Bao'an District,, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

U13; U8; U8PRO; U80 PRO; U80 PRO MAX ; Olynvolt Pocket; Olynvolt Pocket Pro masgre; RX10-PRO Masgre Knee Massager Q8 Electric massager; U13; U15 Electric massager

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-04-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-04-01
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-03-20

Official Correspondent

Fengqing Chen

US Agent Details

Ron Lim Business: LY Consulting Email: tianyuan19880212@gmail.com Phone: (877) 7754526

Related Public Records

Same Entity

Shenzhen Yiran Intelligent Co., 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 3027062656. Last updated year: 2026. Please use registration number 3027062656 when referencing this establishment in official correspondence.