Who else makes this device?

Name: Uroval
Brand: Uroval

Physical Medicine › DiagnosticElectromyograph, Diagnostic

Uroval

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The…

Registry build 21.09.26

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.

2manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Uroval
Listed by	Uroval, United States
FDA product code	IKN
Device type	Electromyograph, Diagnostic
Device class	Class 2
Regulation	21 CFR 890.1375
510(k)	K083679
Record published	2018-09-27
Record revised	2025-02-05 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, manufacturing date, serial number
Sizes	Length 6 ft

Catalogue Numbers

Catalogue numbers for Uroval
Catalogue number	Size	Status
BR5338 UDI Not Req as is component	Length 6 ft	In distribution
BRS System		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
K083679	2009-09-11

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.