KUNSHAN FREEDOMEDI ELECTRIC TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Kunshan City Jiangsu, CN · Registration 3015989577

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
3015989577
FEI Number
3015989577
Entity Name
KUNSHAN FREEDOMEDI ELECTRIC TECHNOLOGY CO., LTD.
City/State/Country
Kunshan City Jiangsu, CN
Establishment Address
BUILDING 1, #1899 SHUIXIU ROAD, YUSHAN TOWN, Kunshan City Jiangsu 215300, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Kunshan Freedomedi Electric Technology Co., Ltd. (Owner Number: 10082262)
Owner / Operator Contact Address
BUILDING 1, #1899 SHUIXIU ROAD, YUSHAN TOWN, Kunshan City, CN-JS 215300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163204
PMA Number
N/A

All Registered Proprietary Names

A04, A05, A07, A08C, A08CL A06, A06L, A08, A08L,A09, A10 Power Wheelchair A05(T3), A08C(DE08), A08CL(DE08L), A11, A12, A12S A13, A15, D05, DE09, GT13

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2021-07-02

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

Kunshan Freedomedi Electric Technology 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
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

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3043165991 HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD. SHIJIAZHUANG Hebei, CN
3036988603 SHENZHEN YATTLL INDUSTRY CO., LTD Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015989577. Last updated year: 2026. Please use registration number 3015989577 when referencing this establishment in official correspondence.
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