Fall Guardian

Fall Guardian Wireless Economy Monitor with chair pad and pager case

Registry build 21.09.26
14manufacturers in China registered for this device type
69catalogue numbers in this listing

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 Fall Guardian
Listed by Smart Caregiver Corporation
FDA product code KMI
Device type Monitor, Bed Patient
Device class Class 1
Regulation 21 CFR 880.2400
Premarket notification Exempt
Record published 2022-07-19
Record revised 2023-09-13 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Fall Guardian
Catalogue number Size Status
FG2BR1-SYS/CS In distribution
FG3BW1-SYS/CS In distribution
FGPT/CS In distribution
FG1C1-SYS In distribution
FG3BR1-SYS/CS In distribution
FG2B90W-SYS In distribution
FG2B45R-SYS/CS In distribution
FG1B45R-SYS/CS In distribution
FG3BR1-SYS In distribution
FG3C1-SYS In distribution
FG3C1-SYS/CS In distribution
FG1B90R-SYS In distribution
FG2FM5-SYS In distribution
FG2000 In distribution
FG3FM5-SYS In distribution
FG3000P/CS In distribution
FG2C1-SYS/CS In distribution
FG1FM7-SYS In distribution
FG2B90R-SYS/CS In distribution
FG3BW1-SYS In distribution
FG3C90-SYS In distribution
FG2C1-SYS In distribution
FG1B90W-SYS/CS In distribution
FG1B45R-SYS In distribution
FG3C90-SYS/CS In distribution
FG3B90R-SYS In distribution
FG2B45W-SYS/CS In distribution
FG300P In distribution
FG3000 In distribution
FG2C45-SYS/CS In distribution
FG1FM5-SYS In distribution
FG2B90R-SYS In distribution
FGPM In distribution
FG1000 In distribution
FG1B90W-SYS In distribution
FG3C45-SYS In distribution
FG3B45R-SYS/CS In distribution
FG3B90W-SYS In distribution
FG2B45R-SYS In distribution
FG3C45-SYS/CS In distribution
FG1B45R-SYS/CS In distribution
FG3B45W-SYS/CS In distribution
FG2BW1-SYS/CS In distribution
FG1BR1-SYS/CS In distribution
FG1C45-SYS In distribution
FG3B45W-SYS In distribution
FG2C90-SYS In distribution
FG3B45R-SYS In distribution
FG1BW1-SYS/CS In distribution
FG1C45-SYS/CS In distribution
FG3B90W-SYS/CS In distribution
FG1C1-SYS/CS In distribution
FG2BR1-SYS In distribution
FG2BW1-SYS In distribution
FGPT In distribution
FG2FM7-SYS In distribution
FG2B90W-SYS/CS In distribution
FG1BR1-SYS In distribution
FG1B45R-SYS In distribution
FG1B90R-SYS/CS In distribution
FG1BW1-SYS In distribution
FG2C45-SYS In distribution
FG3FM7-SYS In distribution
FGPM/CS In distribution
FG3B90R-SYS/CS In distribution
FG2B45W-SYS In distribution
FG1C90-SYS In distribution
FG1C90-SYS/CS In distribution
FG2C90-SYS/CS 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
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
Fall monitor Securitas Healthcare LLC 9

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

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