Who else makes this device?

Name: SafeOp
Brand: SafeOp

SafeOp · Stimulator, Electrical, Evoked Response → Neurology

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Shandong (1), Shaanxi (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWF
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
Shenzhen Launch Electrical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8

Record

Regulatory record for SafeOp
Listed by	Alphatec Spine, Inc., United States
FDA product code	GWF
Device type	Stimulator, Electrical, Evoked Response
Device class	Class 2
Regulation	21 CFR 882.1870
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K182542
Record published	2019-12-31

Specifications

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

Catalogue Numbers

Catalogue numbers for SafeOp
Catalogue number	Size	Status
AIX1190A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stimulator, Electrical, Evoked Response	Inomed Medizintechnik Gmbh	170
Alpine BioMed	Alpine Biomed Aps	132
Natus	Natus Neurology Incorporated	98
Keypoint	Natus Manufacturing Limited	44
Stimulator, Electrical, Evoked Response	Nihon Kohden America, Inc.	41
Stimulator, Electrical, Evoked Response	Nihon Kohden Corp.	38
Powerease™ Instruments	Medtronic Sofamor Danek, Inc.	36
Stimulator, Electrical, Evoked Response	Stryker Leibinger Gmbh & Co. KG	29
Natus	Xltek	27
Isis	Inomed Medizintechnik Gmbh	26
Xltek	Xltek	24
Natus Neurology	Natus Neurology Incorporated	20

Showing 12 of 121. All products under Stimulator, Electrical, Evoked Response

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252842	2026-01-11
K234092	2024-04-19
K213849	2022-03-09

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2026-05-13	Class II	Software Design Change	Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interf	3

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.

SafeOp