Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014302716

FEI Number

3014302716

Entity Name

GUANGDONG KANGSHEN MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

ZHAOQING Guangdong, CN

Establishment Address

WENDE 1ST STREET, DAWANG HI-TECH INDUSTRIAL AREA,, ZHAOQING CITY, GUANGDONG PROVINCE, CHINA, ZHAOQING Guangdong 526238, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGDONG KANGSHEN MEDICAL TECHNOLOGY CO.,LTD. (Owner Number: 10056767)

Owner / Operator Contact Address

WENDE 1ST STREET, DAWANG HI-TECH INDUSTRIAL AREA,, ZHAOQING CITY, GUANGDONG PROVINCE, CHINA, ZHAOQING, CN-GD 526238, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walk aids Electric gynaecology table face mask Electric hospital bed (KS-838, KS-838A, KS-838B, KS-838C, KS-838D, KS-838E, KS-838F, KS-858, KS-858A, KS-858B, KS-858C, KS-858D, KS-828, KS-828A, KS-828B, KS-828C, KS-828D, KS-828E, KS-828F, KS-828J, KS-828G, KS-828H, KS-818, KS-818A, KS-818B, KS-803, KS-888, KS-888A, KS-888B, KS-888C, KS-898, KS-836, KS-836A, KS-806, KS-816, GS-836, GS-838, GS-858, GS-828, GS-806, GS-888, GS-868C, GS-818B, GS-818C, GS-800A, GS-800B, GS-800C) Accompany chair Trolley Medicine cabinet Cane Electric delivery table (GS-811), Electric operation table (GS-820, GS-830) Manual hospital bedManual hospital bed (KS-S001yh, KS-S002yh, KS-S003yh, KS-S005yh, KS-S006yh, KS-S007yh, KS-S101yh, KS-S519fs, KS-S520fs, KS-S101jh, KS-S102jh, KS-S103jh, KS-S105jh, KS-S106jh, KS-S107jh, KS-S108jh, KS-S109jh, KS-S110jh, KS-S402fs, KS-S403fs, KS-S405fs, KS-S406fs, KS-S407fs, KS-S408fs, KS-S409fs, KS-S410fs, KS-S411fs, KS-S412fs, KS-S413fs, KS-520, KS-521, KS-522, KS-523, KS-524, KS-525, KS-526, KS-527, KS-528, KS-529, KS-530, KS-531, KS-532, KS-533, KS-534, KS-S318yh, KS-S319yh, KS-S406yh, KS-S407yh, KS-S408yh, KS-S409yh, KS-S410yh, KS-S411yh, KS-S412yh, KS-S413yh, KS-S415yh, KS-S207yh, KS-S208yh, KS-S209yh, KS-S210yh, KS-S211yh, KS-S212yh, KS-S213yh, KS-S215yh, KS-S216yh, KS-S217yh, KS-S218yh, KS-S412jh, KS-S413jh, KS-S415jh, KS-S416jh, KS-S417jh, KS-S418jh, KS-S419jh, KS-S420jh, KS-S201xt, KS-S202xt, KS-S203xt, KS-S516gk, KS-S517gk, KS-110, KS-110a, KS-110b, KS-120, KS-130, KS-131, KS-132, KS-133, KS-140, KS-141, KS-142, KS-143, KS-S307gk, KS-S308gk, KS-S309gk, KS-S310gk, KS-S311gk, KS-S312gk, KS-S313gk, kS-S315gk, KS-S316gk, KS-S317gk, KS-S318gk, KS-555, KS-556, KS-558, KS-559) KS-S111jh, KS-S112jh, KS-S113jh, KS-S115jh, KS-S116jh, KS-S117jh, KS-S118jh, KS-S119jh, KS-S120jh, KS-S201jh, KS-S202jh, KS-243, KS-244, KS-245, KS-252, KS-253, KS-254, KS-255, KS-302, KS-312, KS-322, KS-323, KS-325, KS-332, KS-333, KS-335, KS-S416yh, KS-S417yh, KS-S418yh, KS-S419yh, KS-S420yh, KS-S501yh, KS-S502yh, KS-S503yh, KS-S505yh, KS-S506yh, KS-S507yh, KS-S411gk, KS-S412gk, KS-S413gk, KS-S415gk, KS-S416gk, KS-S417gk, KS-S418gk, KS-S419gk, KS-S420gk, KS-S501gk, KS-S502gk, KS-S319gk, KS-S320gk, KS-S401gk, KS-S402gk, KS-S403gk, KS-S405gk, KS-S406gk, KS-S407gk, KS-S408gk, KS-S409gk, KS-S410gk, KS-S205xt, KS-S206xt, KS-S207xt, KS-S208xt, KS-S209xt, KS-S210xt, KS-S301gk, KS-S302gk, KS-S303gk, KS-S305gk, KS-S306gk, KS-535, KS-536, KS-538, KS-542, KS-543, KS-545, KS-546, KS-548, KS-549, KS-550, KS-551, KS-552, KS-553, KS-554, KS-S415fs, KS-S416fs, KS-S417fs, KS-S418fs, KS-S419fs, KS-S420fs, KS-S501fs, KS-S502fs, KS-S503fs, KS-S505fs, KS-S506fs, KS-S203jh, KS-S205jh, KS-S206jh, KS-S207jh, KS-S208jh, KS-S209 h, KS-S210jh, KS-S211jh, kS-S212jh, KS-S213jh, KS-S215jh, KS-336, KS-338, KS-342, KS-343, KS-345, KS-346, KS-348, KS-352, KS-353, KS-355, KS-356, KS-358, KS-432, KS-442, KS-452, KS-2032(a), KS-2032(d), KS-2112, KS-2132, KS-S518gk, KS-S519gk, KS-S520gk, KS-513, KS-515, KS-516, KS-517KS-518, KS-519, KS-S520yh, KS-S001ph, KS-S002ph, KS-S003ph, KS--S005ph, ks-s006ph, KS-007ph, KS-S008ph, KS-S009ph, KS-S010ph, KS-S401fs, KS-S311yh, KS-S312yh, KS-S313yh, KS-S315yh, KS-S316yh, KS-S320yh, KS-S401yh, KS-S402yh, KS-S403yh, KS-S405yh, KS-S317yh, KS-S320jh, KS-S401jh, KS-S402jh, KS-S403jh, KS-S405 h, KS-S406jh, KS-S407jh, KS-S408jh, KS-S409jh, KS-S410jh, KS-S411jh, KS-S102yh, KS-S103yh, KS-S105yh, KS-S106yh, KS-S107yh, KS-S108yh, KS-S109yh, KS-S110yh, KS-S111yh, KS-S112yh, KS-S113yh, KS-S216jh, KS-S217jh, KS-S218jh, KS-S219jh, KS-S220jh, KS-S301jh, KS-S302jh, KS-S303jh, KS-S305jh, KS-S306jh, KS-S307 h, KS-S115yh, KS-S116yh, KS-S117yh, KS-S118yh, KS-S119yh, KS-S120yh, KS-S201yh, KS-S202yh, KS-S203yh, KS-S205yh, KS-S206yh, KS-S219yh, KS-S220yh, KS-S301yh, KS-S302yh, KS-S303yh, KS-S305yh, KS-S306yh, KS-S307yh, KS-S308yh, KS-S309yh, KS-S310yh, KS-655, KS-656, KS-910, KS-911, KS-912, KS-913, KS-914, KS-915, KS-1012, KS-1032, KS-1042, KS-1052, KS-2022, KS-2032, KS-S507fs, KS-S508fs, KS-S509fs, KS-S510fs, KS-S511fs, KS-S512fs, KS-S513fs, KS-S515fs, KS-S516fs, KS-S517fs, KS-S518fs, KS-S308jh, KS-S309 h, KS-S310jh, KS-S311jh, KS-S312 h, KS-S313jh, KS-S315jh, KS-S316jh, KS-S317jh, KS-S318jh, KS-S319jh, KS-S508yh, KS-S509yh, KS-S510yh, KS-S511yh, KS-S512yh, KS-S513yh, KS-S515yh, KS-S516yh, KS-S517yh, KS-S518yh, KS-S519yh, KS-S503gk, KS-S505gk, KS-S506gk, KS-S507gk, KS-S508gk, KS-S509gk, KS-S510gk, KS-S511gk, KS-S512gk, KS-S513gk, KS-S515gk, KS-150, KS-151, KS-152, KS-153, KS-211, KS-212, KS-213, KS-215, KS-216, KS-221, KS-232, KS-233, KS-234, KS-235, KS-242, KS-612, KS-622, KS-632, KS-633, KS-635, KS-636, KS-638, KS-642, KS-643, KS-645, KS-646, KS-648, KS-652, KS-658, KS-653, face mask Non-surgical Isolation gown/gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2018-01-14
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2018-01-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-26
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2018-01-14
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2018-01-14
IPS	Cane	Physical Medicine	Class 1	890.3075	2018-01-14
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2018-01-14
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2018-01-14
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-26

Official Correspondent

CHUNMEI Hu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

GUANGDONG KANGSHEN MEDICAL 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014302716. Last updated year: 2026. Please use registration number 3014302716 when referencing this establishment in official correspondence.