GD

The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 50 Lead EEG with 68…

Registry build 21.09.26

The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 50 Lead EEG with 68 Pin Female sub-miniature Dual Inline Connector (50 Lead Wired).

2manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

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

Chinese manufacturers registered for FDA product code GZO
Manufacturer City Province Registered as Device types
Zhongshan Transtek Electronics Co., Ltd. Zhongshan Guangdong Contract manufacturer 5
Qinhuangdao Huisianpu Medical Systems Inc. Qinhuangdao Hebei Manufacturer 4

Record

Regulatory record for GD
Listed by General Devices, United States
FDA product code GZO
Device type Device, Galvanic Skin Response Measurement
Device class Class 2
Regulation 21 CFR 882.1540
Record published 2016-09-23
Record revised 2024-11-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries serial number
Distribution end date 2023-01-01

Catalogue Numbers

Catalogue numbers for GD
Catalogue number Size Status
Prep-Check Plus, 37 pin Withdrawn
Prep-Check Plus, 20 pin Withdrawn
Prep-Check Plus, 25 pin Withdrawn
Prep-Check Plus, 68 pin Withdrawn
Prep-Check Plus, 25 pin Withdrawn
Prep-Check Plus, 50 pin Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sudoscan® Impeto Medical 13
Cadwell Guardian Cadwell Industries, Inc. 2
SudoCheck Medeia Group Ltd 1
Empatica E4 Empatica SRL 1
iTOVi Itovi, LLC 1
Cascade Iomax Cadwell Industries, Inc. 1
SweatC LD Technology LLC 1
Withings® Withings 1
Zyto Hand Cradle Zyto Technologies, Inc. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K993202 1999-12-17

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