Who else makes this device?

Name: Q Patch Downloader
Brand: Q Patch Downloader

Cardiovascular › MonitoringElectrocardiograph, Ambulatory (Without Analysis)

Q Patch Downloader

Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from completed Q Patch session and upload files containing ECG data to…

Registry build 21.09.26

Q Patch Downloader (PC application) → The intended use of the Q Patch Downloader application is to download the data from completed Q Patch session and upload files containing ECG data to the predefine storage space.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MWJ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC	Shanghai	Shanghai	Specification developer	6
DM Systems (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	1

Record

Regulatory record for Q Patch Downloader
Listed by	Medicalgorithmics S.A., Poland
FDA product code	MWJ
Device type	Electrocardiograph, Ambulatory (Without Analysis)
Device class	Class 2
Regulation	21 CFR 870.2800
Establishment	Complaint-file establishment, Manufacturer
510(k)	K210758
Record published	2022-06-23
Record revised	2023-01-23 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Q Patch Downloader
Catalogue number	Size	Status
9.48		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Spacelabs Healthcare	Spacelabs Healthcare (Washington), Inc	60
Welch Allyn, Inc.	Welch Allyn, Inc.	58
Norav NR Series	Norav Medical Inc.	56
Eclipse Pro	Spacelabs Healthcare (Washington), Inc	25
Seer 1000	Getemed Medizin- UND Informationstechnik AG	15
Seer 1000 ECG Cable	Getemed Medizin- UND Informationstechnik AG	12
ECG Cable for Seer 1000	Getemed Medizin- UND Informationstechnik AG	12
Seer	Suzuken Co., Ltd.	12
H12+	Mortara Instrument, Inc.	10
Lifecard	Spacelabs Healthcare (Washington), Inc	10
H3+ Patient Cable	Mortara Instrument, Inc.	10
Spiderview	Microport CRM SRL	9

Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K210758	2022-06-02

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.