Floor MAT Sensor, Wireless, 24″X48″

Floor MAT Sensor, Wireless, 24"X48". Transmitter (CS-TW-TX1) IS Included

Registry build 21.09.26
14manufacturers in China registered for this device type
1catalogue number
1recall

Who Else Makes It

Concentrated in Guangdong (7), Jiangsu (2), Hebei (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMI
Manufacturer City Province Registered as Device types
Chengdu LI REN Electric Co., Ltd. Chengdu Sichuan Contract manufacturer 3
Yuiyn HOO Industrial Limited Dong Guan Guangdong Contract manufacturer 3
Perth Electronic Plastic Limited Company Dongguan Guangdong Contract manufacturer 1
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31
Zhongshan Saxin Electric Heating Technology Co., Ltd. Zhongshan Guangdong Manufacturer 27
Foshan Fuzikon Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 21
Hebei Healthplus Medical Device Co Ltd Handan Hebei Manufacturer 18
Fastsound Acoustic Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Manufacturer 6
Shenzhen Giftshine Technology Co Ltd Shenzhen Guangdong Contract manufacturer 5
Yingkou Henyi Flow Control Inc. Yingkou Liaoning Contract manufacturer 5
Shenzhen Contin Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Showing 12 of 14. All 14 manufacturers in China registered for Monitor, Bed Patient

Record

Regulatory record for Floor MAT Sensor, Wireless, 24″X48″
Listed by Curbell Medical Products, Inc., United States
FDA product code KMI
Device type Monitor, Bed Patient
Device class Class 1
Regulation 21 CFR 880.2400
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-09-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Floor MAT Sensor, Wireless, 24″X48″
Catalogue number Size Status
CS-FMS-W2448 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Smart Caregiver Smart Caregiver Corporation 442
Posey Posey Products, LLC 95
Fall Guardian Smart Caregiver Corporation 69
DeRoyal Deroyal Industries, Inc. 27
Posey Tidi Products, LLC 17
Parasol Patient Fall Prevention System Parasol Medical 17
Monitor, Bed Patient Stryker Sustainability Solutions 13
Medline Medline Industries, Inc. 12
McKesson Mckesson Medical-Surgical Inc. 11
Parasol Wireless Patient Fall Prevention System Parasol Medical 11
Drivemedical Drive DeVilbiss Healthcare 10
Monitor, Bed Patient Sterilmed, Inc. 10

Showing 12 of 251. All products under Monitor, Bed Patient

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
2014-08-05 Class II Component design/selection The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This chan Domestic: 112 units; Foreign: 211 units 2017-02-28

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