Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038130987

FEI Number

3038130987

Entity Name

CONG TY TNHH Wellbeing Technology Co., Ltd.

City/State/Country

TP. Hai Phong, VN

Establishment Address

Lo CN 2 CCN Tien Lang, TT. Tien Lang, H. Tien Lang, TP. Hai Phong 05206, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CONG TY TNHH Wellbeing Technology Co., Ltd. (Owner Number: 10092999)

Owner / Operator Contact Address

Lo CN 2 CCN Tien Lang, TT. Tien Lang, H. Tien Lang, TP. Hai Phong, VN-NOTA 05206, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sharper Image: 1014136,1016287, 1018431, 1019665 Neck and Shoulder Wrap Heater Sharper Image: 1012654,1017191,1012070,1016134,1018018, 1019737, 1018239, Eye Mask Weighted Sharper Image: 1012287, 1011852, 1011827, 1015498, 1011854, 1009822, 1011853 Neck and Shoulder Wrap Sharper Image: 1018436, 1018440, 1018437, 1015078, 1018561, 1019662, 1019783, Neck and Shoulder Wrap Sharper Image: 1018432, 1018434, 1018438, 1018433, 1018435, 1018562, 1018439, Neck and Shoulder Wrap Sharper Image: 1010766, 1013539, 1014961, 1015243, 1017339, 1012549, 1017339 Neck and Shoulder Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-03-14

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

CONG TY TNHH Wellbeing Technology Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038130987. Last updated year: 2026. Please use registration number 3038130987 when referencing this establishment in official correspondence.