Who else makes this device?

Name: ScanVision electrodes
Brand: ScanVision electrodes

Physical Medicine › DiagnosticElectromyograph, Diagnostic

ScanVision Electrodes

Static sEMG electrodes for ScanVisions (wireless static sEMG scanners)

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IKN
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Xian Friendship Medical Electronics Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	10

Record

Regulatory record for ScanVision electrodes
Listed by	Precision Biometrics, Inc., United States
FDA product code	IKN
Device type	Electromyograph, Diagnostic
Device class	Class 2
Regulation	21 CFR 890.1375
510(k)	K123399
Record published	2016-12-13
Record revised	2021-01-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Packaging	Box of 12, bag of 10, bag of 5

Catalogue Numbers

Catalogue numbers for ScanVision electrodes
Catalogue number	Size	Status
PB-212		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Electromyograph, Diagnostic	Medtronic Xomed, Inc.	36
Natus	Natus Neurology Incorporated	21
Natus Neurology	Natus Neurology Incorporated	21
NVM5	Nuvasive, Inc.	19
Epad	Safeop Surgical, Inc.	18
Pulse	Nuvasive, Inc.	16
Electromyograph, Diagnostic	Nihon Kohden Corp.	16
Electromyograph, Diagnostic	Nihon Kohden America, Inc.	15
Natus	Xltek	14
Neuropack S3	Nihon Kohden Corp.	8
Electromyograph, Diagnostic	Medtronic Sofamor Danek, Inc.	7
MyoVision Software	Precision Biometrics, Inc.	5

Showing 12 of 49. All products under Electromyograph, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K123399	2013-08-01

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.