Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011555947

FEI Number

3011555947

Entity Name

Dynamic solution Co., Ltd

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

809, 42, Changeop-ro, Sujeong-gu, Seongnam-si Gyeonggi 13449, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dynamic solution Co., Ltd. (Owner Number: 10048104)

Owner / Operator Contact Address

801, 42, Changeop-ro, Sujeong-gu, Seongnam-si, KR-41 13449, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neofect foot lift NeoMano Neofect Smart Glove / Glove for Home; Neofect Smart Kids / Kids for Home; Neofect Smart Board / Board for Home Neofect Brace & Support Step Dynamics AFO; Neofect Drop Foot Brace; Neofect Shoulder Brace Neofect Extender; Neofect Exender Plus; Neofect Finger Splint; Neofect Resting Brace NeoMano Neofect Smart Balance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2021-03-03
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2019-12-19
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	Class 2	890.5360	2020-10-06
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-11-05
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2019-11-05
JFA	Exerciser, Finger, Powered	Physical Medicine	Class 1	890.5410	2020-10-08
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2020-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Gunmin Jang Business: Eddie Email: jgm@neofect.com Phone: (415) 7952249

Related Public Records

Same Entity

Dynamic solution 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 3011555947. Last updated year: 2026. Please use registration number 3011555947 when referencing this establishment in official correspondence.