Leaf

A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back.

Registry build 21.09.26
14manufacturers in China registered for this device type
8catalogue 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 Leaf
Listed by Smith & Nephew, Inc., United States
FDA product code KMI
Device type Monitor, Bed Patient
Device class Class 1
Regulation 21 CFR 880.2400
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2026-03-03
Record revised 2023-09-07 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Handling environment temperature 41 to 77 °F
Packaging Carton of 10, case

Catalogue Numbers

Catalogue numbers for Leaf
Catalogue number Size Status
66807739 In distribution
66802118 In distribution
66802062 In distribution
66803060 In distribution
66802119 In distribution
66802063 In distribution
66803065 In distribution
66807745 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

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