Who else makes this device?

Name: TOF-S2
Brand: TOF-S2

TOF-S2 · Stimulator, Nerve, Peripheral, Electric → Anesthesiology

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (1), Tianjin (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 KOI
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shenzhen Launch Electrical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Linxens Healthcare (Tianjin) Co., Ltd.	Jinnan District	Tianjin	Contract manufacturer	7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for TOF-S2
Listed by	Idmed Corp., United States
FDA product code	KOI
Device type	Stimulator, Nerve, Peripheral, Electric
Device class	Class 2
Regulation	21 CFR 868.2775
Establishment	Complaint-file establishment, Manufacturer
510(k)	K172690
Record published	2018-07-13
Record revised	2023-12-18 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for TOF-S2
Catalogue number	Size	Status
TOF-S2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stimulator, Nerve, Peripheral, Electric	GE Healthcare Finland OY	7
WiTOF	Idmed Corp.	6
TwitchView™	Blink Device Company	6
Fisher & Paykel Healthcare	Fisher & Paykel Healthcare, Ltd.	5
Halyard	Avanos Medical, Inc.	5
Avanos	Avanos Medical, Inc.	5
Smart Cable NMT Module and Accessories	Nihon Kohden Corp.	4
Eye adapter TOF3D	Mipm Mammendorfer Institut für Physik und Medizin GmbH	2
TetraSens Pediatric	Senzime AB (Publ.)	2
Temperature sensor TOF3D	Mipm Mammendorfer Institut für Physik und Medizin GmbH	2
TetraGraph	Senzime AB (Publ.)	2
TetraSensitive	Senzime AB (Publ.)	2

Showing 12 of 61. All products under Stimulator, Nerve, Peripheral, Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243339	2025-06-23
K172690	2018-05-31

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.

TOF-S2