Who else makes this device?

Name: Chalgren
Brand: Chalgren

Neurology › DiagnosticDevice, Nerve Conduction Velocity Measurement

Chalgren

Reusable 30 mm Bar Electrode, EMG, 9 mm Concave Tin Discs, Shielded Leadwire

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JXE
Manufacturer	City	Province	Registered as	Device types
Pine Moon Electronics Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8

Record

Regulatory record for Chalgren
Listed by	Chalgren Enterprises, Inc., United States
FDA product code	JXE
Device type	Device, Nerve Conduction Velocity Measurement
Device class	Class 2
Regulation	21 CFR 882.1550
510(k)	K923665
Record published	2016-09-09
Record revised	2023-12-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number
Sizes	Length 24 to 48 in

Catalogue Numbers

Catalogue numbers for Chalgren
Catalogue number	Size	Status
279-930-48TP	Length 48 in	In distribution
277-930-24TP	Length 24 in	In distribution
277-930-48TP	Length 48 in	In distribution
277-930-36STP	Length 36 in	In distribution
279-930-24TP	Length 24 in	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ultra-Drive® Tool	Biomet Orthopedics	40
Advance	Neurometrix, Inc.	18
DPNCheck	Impulse Technology LLC	7
Rhythmlink®	Rhythmlink International, LLC	4
Ultra-Drive	Biomet Orthopedics	3
Cadwell Guardian	Cadwell Industries, Inc.	2
NC-stat DPNCheck	Neurometrix, Inc.	2
NeMus 1	EB Neuro SPA	2
Sierra Wave	Cadwell Industries, Inc.	2
Cascade	Cadwell Industries, Inc.	2
NeMus PC Peripheral	EB Neuro SPA	1
Focus	Neurosoft, OOO	1

Showing 12 of 32. All products under Device, Nerve Conduction Velocity Measurement

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K923665	1992-10-05
K921504	1992-09-11

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.