HolterCare

The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient’s long-term, continuous,…

Registry build 21.09.26

The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient’s long-term, continuous, ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable:  The evaluation of arrhythmias and ischemic attacks.  The reporting of PQRST intervals.  Clinical and epidemiological research studies.  The evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery).  The evaluation of patients with Pacemakers. The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient. This device is available for sale to, or on the order of, a licensed physician only and is not intended for any home-use applications.

10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DQK
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Dongguan Ergotron Precision Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd Shenzhen Guangdong Manufacturer 7
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC Shanghai Shanghai Specification developer 6
Shenzhen Carewell Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for HolterCare
Listed by Scottcare Corporation, THE
FDA product code DQK
Device type Computer, Diagnostic, Programmable
Device class Class 2
Regulation 21 CFR 870.1425
510(k) K042463
Record published 2016-09-19
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for HolterCare
Catalogue number Size Status
HolterCare In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EnSite™ St. Jude Medical 177
Computer, Diagnostic, Programmable St. Jude Medical 57
MediGuide™ St. Jude Medical 41
AcQMap Acutus Medical, Inc. 38
WorkMate Claris™ St. Jude Medical 35
iLab Ultrasound Imaging System Boston Scientific Corporation 32
Rhythmia™ Mapping System Boston Scientific Corporation 31
Sentinel Spacelabs Healthcare (Washington), Inc 28
Rhythmia HDx™ Boston Scientific Corporation 26
EnSite Precision™ St. Jude Medical 23
PathfinderSL Spacelabs Healthcare (Washington), Inc 22
Labsystem™ PRO Boston Scientific Corporation 19

Showing 12 of 228. All products under Computer, Diagnostic, Programmable

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