Pathway

Pathway® NMR 400 Quad Channel EMG System

Registry build 21.09.26
7manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Shanghai (1), Hunan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HIR
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Dongguan Q & S Electronic Manufacturing Company Limited Dongguan Guangdong Contract manufacturer 5
Suzhou Armocon Technology Co., Ltd. Jiangsu Jiangsu Contract manufacturer 5
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Hunan Accurate BIO-Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 7
Guangdong Yuxiang Silicone & Plastic Co., Ltd. Zhongshan Guangdong Manufacturer 2

Record

Regulatory record for Pathway
Listed by Prometheus Group OF NEW Hampshire Limited, THE
FDA product code HIR
Device type Perineometer
Device class Class 2
Regulation 21 CFR 884.1425
Record published 2016-09-26
Record revised 2024-07-18 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Pathway
Catalogue number Size Status
MR-25 In distribution
MR-20 In distribution
6320 In distribution
NMR 200 In distribution
NMR400 In distribution
MR-10 In distribution
MR-15 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Peritron Laborie Medical Technologies, Canada ULC 4
Perifit Care+ X6 Innovations 3
Levina ZMI Electronics Ltd. 3
Flyte In-Home Pelvic Floor Treatment Pelvital USA, Inc. 2
MEP Personal Medical Corp. 2
Perifit X6 Innovations 2
IVS-2 Personal Medical Corp. 2
FemiScan Bittium Biosignals Ltd. 2
SenseRx — Anal/Small Vaginal and Vaginal EMG Personal Medical Corp. 2
Intimate Rose Plus EV Holdings Inc 1
InTone® Nasp Incontrol Medical, LLC 1
InTone® by Viveve Incontrol Medical, LLC 1

Showing 12 of 36. All products under Perineometer

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