What is FDA product code GWQ?

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Neurology › DiagnosticFull-Montage Standard Electroencephalograph

WAVi Scan Kit

Name: WAVi Scan Kit
Brand: WAVi Scan Kit

Catalogue number WK200, listed by Wavi Co, United States, under Full-Montage Standard Electroencephalograph. 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

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (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 GWQ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Xian Friendship Medical Electronics Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	10
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for WAVi Scan Kit
Listed by	Wavi Co, United States
FDA product code	GWQ
Device type	Full-Montage Standard Electroencephalograph
Device class	Class 2
Regulation	21 CFR 882.1400
Establishment	Manufacturer
510(k)	K162460
Record published	2026-03-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for WAVi Scan Kit
Catalogue number	Size	Status
WK200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Natus	Xltek	54
Trackit	Lifelines Ltd.	24
Full-Montage Standard Electroencephalograph	Nihon Kohden Corp.	20
Enobio Dx	Neuroelectrics Barcelona SL	19
Compumedics Neuvo	Compumedics Limited	19
Natus	Natus Neurology Incorporated	18
X-Series	Advanced Brain Monitoring, Inc.	16
Full-Montage Standard Electroencephalograph	Nihon Kohden America, Inc.	15
Grass	Xltek	13
Seer Home	Seer Medical Pty, Ltd.	10
Compumedics SynAmps RT	Compumedics Limited	9
Component Neuromonitoring System	Moberg Research, Inc.	9

Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213900	2022-05-06

Recalls

1 of these is 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
2023-12-08	Class II	No Marketing Application	Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.	281

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.