Accessories

KIT, Retaining, Foot Panel, Care 100, AL

Registry build 21.09.26
95manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
1recall

Who Else Makes It

Concentrated in Guangdong (32), Jiangsu (20), Hebei (11). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FNL
Manufacturer City Province Registered as Device types
Hangzhou Dunli Medical Instruments Co., Ltd. Hangzhou Zhejiang Contract manufacturer 16
Foshan Dongfang Medical Equipment Manufactory(Ltd) Foshan Guangdong Contract manufacturer 14
Genteel Homecare Products Co., Ltd. Foshan Guangdong Contract manufacturer 12
Jiangyin Newrise Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 10
Jiaxing Kalanchoe Medical Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 8
Jiangmen Jia Mei Medical Products Co., Ltd. Heshan Guangdong Contract manufacturer 8
Ningbo Hecai Medical Equipment Co., Ltd. Ningbo Zhejiang Contract manufacturer 8
Nantong Shunlong Physical Therapy Equipment Co., Ltd. Rugao Jiangsu Contract manufacturer 6
Chengdu LI REN Electric Co., Ltd. Chengdu Sichuan Contract manufacturer 3
Yuiyn HOO Industrial Limited Dong Guan Guangdong Contract manufacturer 3
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Dragon Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 48

Showing 12 of 95. All 95 manufacturers in China registered for Bed, Ac-Powered Adjustable Hospital

Record

Regulatory record for Accessories
Listed by Joerns Healthcare, United States
FDA product code FNL
Device type Bed, Ac-Powered Adjustable Hospital
Device class Class 2
Regulation 21 CFR 880.5100
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-04-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Accessories
Catalogue number Size Status
N119 In distribution
N300AL In distribution
F168AL In distribution
F026AL In distribution
N495AL In distribution
N720 In distribution
N517 In distribution
N503AL In distribution
N518 In distribution
N641 In distribution
N301AL In distribution
N351AL In distribution
N718 In distribution
N501AL In distribution
N302AL In distribution
N496AL In distribution
F17TMAL In distribution
F028 In distribution
N431 In distribution
N228AL In distribution
N579TRTAL In distribution
N353AL In distribution
N529AL In distribution
N352AL In distribution
N497AL In distribution
N717 In distribution
F14SCAL In distribution
F18AL In distribution
N579AL In distribution
N190 In distribution
N511 In distribution
N606 In distribution
N104 In distribution
N106 In distribution
N341AL In distribution
N401AL In distribution
N303AL In distribution
N348AL In distribution
F025AL In distribution
N494AL In distribution
N354AL In distribution
N818 In distribution
39000965 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Drive Drive DeVilbiss Healthcare 190
Electrical Hospital Bed Paramount BED Co., Ltd. 164
MC Healthcare Span-America Medical Systems, Inc. 160
NOA Medical Industries, Inc. Hoffmann NOA Medical Industries, LLC 99
Posey Posey Products, LLC 95
Drivemedical Drive DeVilbiss Healthcare 94
Enterprise Arjohuntleigh AB 80
silverfox Silverfox Corporation Limited 77
Electrical Hospital Bed with Digital Scale Paramount BED Co., Ltd. 70
Basic American Medical Products GF Health Products, Inc 66
Bed, Ac-Powered Adjustable Hospital Gendron, Inc. 50
WeCare Response Bed Joerns Healthcare 42

Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K951735 1995-08-18

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2014-09-24 Class II Device Design The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal. 3135 2016-02-01

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer