Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012579728

FEI Number

3012579728

Entity Name

FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO. LTD

City/State/Country

Foshan City Guangdong, CN

Establishment Address

Youhe Industry Area, Luoxing, Danzao Town, Nanhai District, Foshan City Guangdong 528216, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Foshan Huafukang Medical Technology Co. Ltd (Owner Number: 10051458)

Owner / Operator Contact Address

Youhe Industry Area, Luoxing, Danzao Town, Nanhai District, Foshan City, CN-GD 528216, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HFK HFK-3367KD-3, HFK-3367KD-4, HFK-3367KD-5, HFK-3367KD-6, HFK-3367KD-7, HFK-3367KD-8, HFK-3375KD, HFK-3375KD-1, HFK-3376LKD, HFK-3346-1, HFK-3348-1, HFK-3400, HFK-3401, HFK-3402, HFK-3403, HFK-3404, HFK-3405, HFK-3406, HFK-3407, HFK-3375KD-2, HFK-3376KD, HFK-3376KD-1, HFK-3376KD-2, HFK-3315KD, HFK-3374S, HFK-3374L, HFK-3375KD-3, HFK-3376KDS, Commode Chairs and Commode chair Spare Parts and Toilet Raiser: HFK-3301-5, HFK-3304, HFK-3326, HFK-3327, HFK-3328, HFK-3397, HFK-3398, HFK-3399, HFK-3301-5KD, HFK-3301L, HFK-3327-1, HFK-3352-1, HFK-3352-4, HFK-3362KD, HFK-3367KD-2, HFK-3385, HFK-3386, HFK-3387, HFK-3388, HFK-3389, HFK-3390, HFK-3391, HFK-3392, HFK-3393, HFK-3394, HFK-3395, HFK-3396, HFK-3373, HFK-3374, HFK-3375, HFK-3376, HFK-3377, HFK-3378, HFK-3379, HFK-3380, HFK3381, HFK-3382, HFK-3383, HFK-3384, HFK-3305, HFK-3306, HFK-3307, HFK-3308, HFK-3309, HFK-3310, HFK-3311, HFK-3312, HFK-3313, HFK-3316, HFK-3317, HFK-3318, HFK-3320, HFK-3321, HFK-3322, HFK-3323, HFK-3324, HFK-3325, HFK-3328-1, HFK-3330, HFK-3331-2, HFK-3335, HFK-3336, HFK-3329, HFK-3331, HFK-3347, HFK-3352, HFK-3362, HFK-3332, HFK-3332-1, HFK-3333, HFK-3333-1, HFK-3334, HFK-3334-1, HFK-3337, HFK-3338, HFK-3339, HFK-3340, HFK-3341, HFK-3342, HFK-3343, HFK-3345, HFK-3346, HFK-3347-1, HFK-3348, HFK-3349 HFK-3408, HFK-3409 HFK-3326-1, HFK-3351, HFK-3359, HFK-3367KD, HFK-3301-24, HFK-3319-1, HFK-3344, HFK-3352-3, HFK-3369, HFK-3302, HFK-3303, HFK-3363, HFK-3364, HFK-3365, HFK-3366, HFK-3367, HFK-3367KD-1, HFK-3368, HFK-3369, HFK-3370, HFK-3371, HFK-3372, HFK-3350, HFK-3352-2, HFK-3352-3, HFK-3352A, HFK-3353, HFK-3355-1, HFK-3356, HFK-3357, HFK-3358, HFK-3360, HFK-3361, HFK-9410 Stand Assist Transfer: HFK-9405, HFK-9405-1, HFK-9405-2, HFK-9406, HFK-9406-1, HFK-9407, HFK-9407-1, HFK-9408, HFK-9409, HFK-9385, HFK-9386, HFK-9387, HFK-9388, HFK-9389 HFK-9368W-R, HFK-9368W-L, HFK-9331W, HFK-9333W, HFK-9321-1, HFK-9321W-1, HFK-9381, HFK-9382, HFK-9383, HFK-9384, HFK-9303, HFK-9304, HFK-9305, HFK-9306, HFK-9307, HFK-9308, HFK-9309, HFK-9310, HFK-9313, HFK-9314, HFK-9315, HFK-9324, HFK-9325, HFK-9326, HFK-9327, HFK-9330, HFK-9342L, HFK-9344, HFK-9347, HFK-9348, HFK-9349, HFK-9353, HFK-9354, HFK-9379, HFK-9380; HFK-9342W-1, HFK-9370, HFK-9306-1, HFK-9307-1, HFK-9313B, HFK-9346, HFK-9347-1, HFK-9359, HFK-9371A, HFK-9371B, HFK-9355, HFK-9358, HFK-9360, HFK-9361, HFK-9362, HFK-9363, HFK-9365, HFK-9366, HFK-9310-2, HFK-9337, HFK-9342W, Crutch Holder and Walking Aid Spare Parts: HFK-9331 (L, M, S), HFK-9333, HFK-9319 (L, M, S), HFK-9320, HFK-9321, Cane, Walking Cane /Seat, Crutches, Crutch Holder and Walking Aid Spare Parts, Cane, Walking Cane /Seat: HFK-9301, HFK-9320W, HFK-9321W, HFK-9319-R, HFK-9319-L, HFK-9319W-R, HFK-9319W-L, HFK-9368, HFK-9368W, HFK-9368-R, HFK-9368-L, HFK-9322B, HFK-9350, HFK-9351m, HFK-9352m, HFK-9357, HFK-2403, HFK-2303, HFK-2305, HFK-9333-1, HFK-9352L, HFK-9357S, HFK-9372, HFK-9373, HFK-9374, HFK-9324W, HFK-9326W, HFK-9349W, HFK-9342, HFK-9375, HFK-9376, HFK-9377, HFK-9378, HFK HFK HFK-5120, HFK-5121, HFK-5122, HFK-5124, HFK-5124-1, HFK-5125, HFK-5123, HFK-5126, HFK-5130, HFK-5130-1, HFK-5131, HFK-5131-1, HFK-5131-2, HFK-2504, HFK-5119, HFK-5127, HFK-5127-1, HFK-5128, HFK-5129, HFK-5132, HFK-5133, HFK-5134, Bed Rail: HFK-5113, HFK-5114, HFK-5115, HFK-5115-1, HFK-5115-2, HFK-5116, HFK-5116-2, HFK-5117, HFK-5118, HFK-5119-1, HFK-5135, HFK-5136, HFK-5137, HFK-5138, HFK-5139, HFK-5140, HFK-5141 HFK-9222-2, HFK-9222C, HFK-9222C-1, HFK-9223-1, HFK-9223-2, HFK-9241-8, HFK-9228B, HFK-9228C, HFK-9232, HFK-9232-8, HFK-9132LT-1, HFK-9132LT-2, HFK-9132LT-3, HFK-9132LT-4, HFK-9132LT-5, HFK-9134-1, HFK-9136, HFK-9140, HFK-9102, HFK-9236E, HFK-9241, HFK-9210KD-7, HFK-2410, HFK-8201, HFK-8202, HFK-8203, HFK-8204, HFK-8205, HFK-9201SW, HFK-9279, HFK-9280KD, HFK-9282, HFK-9283, HFK-9285, HFK-9285-1, HFK-9273, HFK-9273-1, HFK-9273-2, HFK-9274, Walker and Walker Spare Parts: HFK-9101A, HFK-9105A, HFK-9106, HFK-9109A, HFK-9112, HFK-9114, HFK-9132LT, HFK-9106KD, HFK-9218-8A, HFK-9220-1, HFK-9236B-6, HFK-9269KD-3, HFK-9269-4, HFK-9288B-2; HFK-9209KDB-1, HFK-9209KDB-2, HFK-9209KDB-3, HFK-9210KD-1, HFK-9210KD-2, HFK-9210KD-3, HFK-9210KD-5, HFK-9210KD-6, HFK-9210B, HFK-9211, HFK-9211B, HFK-9212, HFK-9213, HFK-9218-8, HFK-9218-6, HFK-9219, HFK-9219B, HFK-9220, HFK-9222, HFK-9240B, HFK-9240B-1, HFK-9240B-2, HFK-9240BL-1, HFK-9267-1, HFK-9269-1, HFK-9269-2, HFK-9269-3, HFK-9269KD, Knee Walker and Knee Walker Spare Parts: HFK-9225, HFK-9227, HFK-9270, HFK-9271, HFK-9272, HFK-9276, HFK-9277KD, HFK-9203, HFK-9206, HFK-9214A, HFK-9214L, HFK-9214LKD, HFK-9214B, HFK-9215, HFK-9216, HFK-9217, HFK-9221, HFK-9224, Rollator and Rollator Spare Parts: HFK-9201M, HFK-9202, HFK-9204, HFK-9205S, HFK-9208L, HFK-9209KDB, HFK-9210, HFK-9219-2, HFK-9219-3, HFK-9219KD, HFK-9219KD-1, HFK-9219B-1, HFK-9220B-1, HFK-9220B-2, HFK-9220C, HFK-9222-1, HFK-9269KD-1, HFK-9288A, HFK-9236B-1, HFK-9236B-2, HFK-9294-1, HFK-9294-2, HFK-9295KD, HFK-9201L, HFK-9201-1, HFK-9225-1, HFK-9225-2, HFK-9270-1, HFK-9270-2, HFK-9270-3, HFK-9270-4, HFK-9270-7, HFK-9277, HFK-9280, HFK-9280KD-1, HFK-9201LS-1, HFK-9201LSB, HFK-9201LSB-1, HFK-9201M-1, HFK-9201B, HFK-9201B-1, HFK-9201S, HFK-9201S-1, HFK-9201SB, HFK-9134, HFK-9102-1, HFK-9102-2, HFK-9102-3, HFK-9105-1, HFK-9105A-3, HFK-9105A-5, HFK-9106-3, HFK-9106-5, HFK-9201-2, HFK-9201-3, HFK-9202B, HFK-9202BC-1, HFK-9202F, HFK-9204-1, HFK-9204-2, HFK-9204-3, HFK-9204-4, HFK-9204T, HFK-9144, HFK-9145, HFK-9146, HFK-9147, HFK-9148, HFK-9149, HFK-9150, HFK-9151, HFK-9152, HFK-9153, HFK-9154 HFK-9270-5, HFK-9280KD-2, HFK-9225G1-8, HFK-9225G1-12, HFK-9270-6 HFK-9233-1, HFK-9235, HFK-9235D, HFK-9235C-1, HFK-9236T3, HFK-9236T4, HFK-9236C-8, HFK-9236C-12, HFK-9236D, HFK-9201MB, HFK-9202D, HFK-9202E, HFK-9202G, HFK-9202S, HFK-9202C, HFK-9205AL, HFK-9208LB, HFK-9208LB-2, HFK-9209KD-1, HFK-9223B, HFK-9242, HFK-9232B, HFK-9234T, HFK-9240BL, HFK-9250KD, HFK-9269KD-2, HFK-9269B, HFK-9289S-8, HFK-9252, HFK-9253, HFK-9254, HFK-9255, HFK-9256, HFK-9257, HFK-9258, HFK-9259, HFK-9260, HFK-9261, HFK-9262, HFK-9263, HFK-9108, HFK-9112-1, HFK-9109A-5, HFK-9113, HFK-9135-1, HFK-9135-2, HFK-9137, HFK-9138, HFK-9139, HFK-9141, HFK-9142, HFK-9243DT, HFK-9244, HFK-9245, HFK-9246, HFK-9247, HFK-9247D, HFK-9247L, HFK-9248, HFK-9249, HFK-9250, HFK-9251, HFK-9210KDBV, HFK-9210KDB-2, HFK-9210KDB-3, HFK-9211-10, HFK-9211-1, HFK-9211B-1, HFK-9212KD, HFK-9212KD-1, HFK-9223, HFK-9226, HFK-9228, HFK-9229, HFK-9231, HFK-9233, HFK-9234B, HFK-9235A, HFK-9235B, HFK-9235C, HFK-9236B, HFK-9210KDB-4, HFK-9211-2, HFK-9211B-2, HFK-9213-1, HFK-9213-6, HFK-9214L-1, HFK-9219-4, HFK-9220D, HFK-9222B, HFK-9236C, HFK-9236T1, HFK-9236T2, HFK-9267, HFK-9269, HFK-9288, HFK-9289-6, HFK-9289-8, HFK-9289S-6, HFK-9202BC, HFK-9208M, HFK-9208L-1, HFK-9208LB-1, HFK-9208LB-3, HFK-9209KD, HFK-9209KD-2, HFK-9210KD-4, HFK-9210KDB-1, HFK-9207, HFK-9210KD, HFK-9210KDB, HFK-9220B, HFK-9231B, HFK-9232-6, HFK-9241-10, HFK-9242B, HFK-9288B, HFK-9292, HFK-9264, HFK-9265, HFK-9266, HFK-9268, HFK-9287, HFK-9293, HFK-9294, HFK-9295, , HFK-9297, HFK-9298, HFK-9201LS, HFK-9230, HFK-9237, HFK-9238, HFK-9239, HFK-9240, HFK-9240-1, HFK-9240-2, HFK-9243, HFK-9243-1, HFK-9243CT, HFK-9243CTL, HFK-9275, HFK-9278, HFK-9281, HFK-9284, HFK-9286, HFK-9290, HFK-9291, HFK-9296, HFK-9299, HFK-9225G-8, HFK-9225G-12, HFK-9212KD-2, HFK-9213-2, HFK-9213-3, HFK-9213-4, HFK-9213-5, HFK-9213-7, HFK-9213-8, HFK-9214C, HFK-9218-10, HFK-9219-1 Handrail and Grab Bar: HFK-3125, HFK-3132, HFK-3126, HFK-3127, HFK-3128, HFK3130, HFK-3136, HFK-3314, HFK-3315, HFK-3354 HFK-3177, HFK-3178, HFK-3179, HFK-3180 HFK-3127A, HFK-3127B, HFK-3127C, HFK-3127D, HFK-3127E, HFK-3127F, HFK-3125-1, HFK-3151, HFK-3152, HFK-3153, HFK-3154, HFK-3161, HFK-3162, HFK-3162-1, HFK-3163, HFK-3164, HFK-3165, HFK-3166, HFK-3167, HFK-3168, HFK-3169, HFK-3170; HFK-3102C, HFK-3102C-1, HFK-3104-1, HFK-3109-1, HFK-3109-2, HFK-3109T, HFK-3110-1, HFK-3141, HFK-3144, HFK-3144-1, HFK-3146, HFK-3146A, HFK-3146-1, HFK-3146-1A, HFK-3150, HFK-3102D, HFK-3104-2, HFK-3109-3, HFK-3111A, HFK-3119, HFK-3155, HFK-3156, HFK-3157, HFK-3158, HFK-3159, HFK-3160, HFK-2408, HFK-2409, HFK-2411, HFK-2412, HFK-2413, HFK-2414, Shower Chair and Shower Chair Spare Parts: HFK-3102A, HFK-3107, HFK-3108, HFK-3109, HFK-3113, HFK-3114, HFK-3118, HFK-3130, HFK-3130-1, HFK-3130-1A, HFK-3148, HFK-3149, HFK-3171, HFK-3172, HFK-3173, HFK-3174, HFK-3175, HFK-3176, HFK-3121-1, HFK-3140, HFK-3141-1, HFK-3142, HFK-3143, HFK-3145, HFK-3145-1, HFK-3146B, HFK-3147, HFK-3146C, HFK-3146D, HFK-3121, HFK-3131, HFK-3133, HFK-3135, HFK-3102B, HFK-3104, HFK-3110, HFK-3111, HFK-3112, HFK-3120, HFK-3122, HFK HFK HFK HFK-5311 Electric Bed: HFK-5301, HFK-5302, HFK-5303, HFK-5304, HFK-5305, HFK-5306, HFK-5307, HFK-5308, HFK-5309, HFK-5310, HFK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2016-03-21
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2016-03-21
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-03-21
IPS	Cane	Physical Medicine	Class 1	890.3075	2016-03-21
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-03-21
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2016-03-21
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2026-06-18
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2016-03-21
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2016-04-27
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2016-03-21
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2016-03-21
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2016-08-22
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2025-07-01
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2017-05-04

Official Correspondent

Haiwei Zhang

US Agent Details

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

Related Public Records

Same Entity

Foshan Huafukang 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
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 3012579728. Last updated year: 2026. Please use registration number 3012579728 when referencing this establishment in official correspondence.