Who else makes this device?

Name: Neurolign Dx Svng
Brand: Neurolign Dx Svng

Neurolign Dx Svng

Catalogue number Dx SVNG, listed by Spryson America Inc, United States, under Nystagmograph. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3recalls on this code

Who Else Makes It

Concentrated in Guangdong (2), Beijing (1).

Chinese manufacturers registered for FDA product code GWN
Manufacturer	City	Province	Registered as	Device types
Isen Tech.&Trading Co., Ltd.	Beijing	Beijing	Manufacturer	2
E-Business International Inc.	Shenzhen	Guangdong	Exporter	2
Huizhou Maxway Technology Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	2

Record

Regulatory record for Neurolign Dx Svng
Listed by	Spryson America Inc, United States
FDA product code	GWN
Device type	Nystagmograph
Device class	Class 2
Regulation	21 CFR 882.1460
Establishment	Manufacturer
510(k)	K143607
Record published	2020-07-01
Record revised	2026-07-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Neurolign Dx Svng
Catalogue number	Size	Status
Dx SVNG		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GN Otometrics A/S	Natus Medical Denmark ApS	17
Interacoustics	Interacoustics A/S	15
VNG	Inventis SRL	9
Instrumentation Difra SA	Instrumentation Difra SA	8
Nystagmograph	Medtronic PS Medical	7
Instrumentation Difra	Instrumentation Difra SA	7
Otometrics	Natus Medical Denmark ApS	5
Vestibular First	Vestibular First	4
Micromedical Technologies	Micromedical Technologies, Inc.	3
Complete Monocular wireless Smart Cam system with Xpress mask	Synapsys SA	2
Synapsys Vhit	Inventis SRL	2
EYE-Sync	Neurosync, Inc.	2

Showing 12 of 37. All products under Nystagmograph

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Neurolign Dx Svng
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Spryson America Inc	510(k) number	2015-07-21	Class II	No Marketing Application	The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.	45	2016-09-27

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-04-30	Class II	Software design	complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.	140	2017-04-17
2013-11-21	Class II	No Marketing Application	The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.	148	2015-07-20

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.