Who else makes this device?

Name: MicroFit
Brand: MicroFit

Cardiovascular › DiagnosticComputer, Diagnostic, Pre-Programmed, Single-Function

MicroFit

Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale,…

Registry build 21.09.26

Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale, non-invasive automatic blood pressure monitor, analog to digital interface unit (CTI), and software (to be installed on the user’s PC computer).

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXG
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40
Shenzhen Comen Medical Instruments Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for MicroFit
Listed by	Microfit, Inc., United States
FDA product code	DXG
Device type	Computer, Diagnostic, Pre-Programmed, Single-Function
Device class	Class 2
Regulation	21 CFR 870.1435
510(k)	K830003
Record published	2016-09-26
Record revised	2019-11-08 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for MicroFit
Catalogue number	Size	Status
FAS-2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LiDCO Ltd	Lidco Ltd.	133
LiDCO	Lidco Ltd.	32
Transonic	Transonic Systems, Inc.	31
Computer, Diagnostic, Pre-Programmed, Single-Function	Edwards Lifesciences Technology Sarl	23
Retia Medical	Retia Medical, LLC	17
EV1000	Edwards Lifesciences Technology Sarl	11
Computer, Diagnostic, Pre-Programmed, Single-Function	GE Healthcare Finland OY	5
Pediasat	Edwards Lifesciences Technology Sarl	4
LiDCO	Masimo Corporation	4
ICU Medical	ICU Medical, Inc	4
Cnap® Monitor 500 HD	Cnsystems Medizintechnik GmbH	4
Vigileo	Edwards Lifesciences Technology Sarl	3

Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K830003	1983-03-10

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.