WINBACK GO EAST Co Ltd

FDA Device Registration & Listing · Wonju-si Gangwon, KR · Registration 3016512343

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016512343
FEI Number
3016512343
Entity Name
WINBACK GO EAST Co Ltd
City/State/Country
Wonju-si Gangwon, KR
Establishment Address
161, Usangongdan-Gil, Wonju-si Gangwon 26335, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
WINBACK GO EAST Co Ltd (Owner Number: 10062809)
Owner / Operator Contact Address
161, Usangongdan-gil, Wonju-si, KR-42 26335, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230037
PMA Number
N/A

All Registered Proprietary Names

BACK 4 Massager, Radiofrequency Induced Heat Winback Back 3SE Hi-TENS Back 3 Color BACK 3TX BACK 3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-09-19
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-09-19
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2020-03-09
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-06-27
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2022-12-16
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-07-24

Official Correspondent

Daisy Jeong

US Agent Details

David FURR Business: FDC Services LLC Email: davidfurr@fdcservices.com Phone: (512) 9069654

Related Public Records

Same Entity

WINBACK GO EAST 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
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016512343. Last updated year: 2026. Please use registration number 3016512343 when referencing this establishment in official correspondence.
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