Kinesis Balance

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors…

Registry build 21.09.26

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.

7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (4), Zhejiang (1), Hubei (1).

Chinese manufacturers registered for FDA product code JFC
Manufacturer City Province Registered as Device types
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Wenzhou Caretek Medical Device Co., Ltd. Wenzhou Zhejiang Contract manufacturer 30
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Unimed Medical Supplies Inc Shenzhen Guangdong Contract manufacturer 15
Wuhan Zjzk Technology Co., Ltd. (AKA Wuhan Zjkc Technology Co., Ltd.) Wuhan Hubei Manufacturer 7
Fourier Intelligence Inc. Shanghai Shanghai Private-label distributor 6
Macmed Technology Inc. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Kinesis Balance
Listed by Kinesis
FDA product code JFC
Device type System, Pressure Measurement, Intermittent
Device class Class 1
Regulation 21 CFR 890.1600
Premarket notification Exempt
Record published 2023-02-22
Record revised 2026-05-18 (version 2)

Specifications

Specifications
MRI safety MR Safe
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Kinesis Balance
Catalogue number Size Status
2.0.1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Orantech Orantech Inc. 215
BodiTrak Vista Medical Technologies, Inc. 63
Bpms Evolution Tekscan, Inc. 11
Strideway MR Tile Tekscan, Inc. 7
Strideway SR Tile Tekscan, Inc. 7
Strideway HR Tile Tekscan, Inc. 7
HR Walkway VersaTek Tekscan, Inc. 6
FeetMe Monitor Charging Case FTM-DK-CC Feetme 4
Materialise Footscan Pro Level pressure plate Materialise Motion 4
MatScan Evolution Tekscan, Inc. 4
VU Wellsense Technologies Ltd. 3
MatScan VersaTek Tekscan, Inc. 3

Showing 12 of 183. All products under System, Pressure Measurement, Intermittent

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