WiTOF
The FDA filing identifies WiTOF as a neuromuscular transmission station, or nerve stimulator, for adult patients receiving neuromuscular blockade in operating, recovery or intensive care…
The FDA filing identifies WiTOF as a neuromuscular transmission station, or nerve stimulator, for adult patients receiving neuromuscular blockade in operating, recovery or intensive care settings.
The system uses electrical nerve stimulation and a three-dimensional accelerometer to measure movement in the corresponding muscle.
Listed Item
WiTOF Demonstration kit (WiTOF-MU, power supply, clamp, hand and foot sensors (WiTOFS and WiTOF-FS), user manual, patient simulator)
Monitoring
The device is used by health professionals.
The WiTOF system includes a station, a wireless hand sensor and a U.S. AC power supply.
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.
| 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
| 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) | K243339 |
| Record published | 2025-12-19 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WiTOF-DEMO | In distribution | |
| WiTOF-S | In distribution | |
| WiTOF-FS | In distribution | |
| WiTOF-MU | In distribution | |
| WiTOF-MU | In distribution | |
| WiTOF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Nerve, Peripheral, Electric | GE Healthcare Finland OY | 7 |
| 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 |
| Thumb adapter TOF3D | Mipm Mammendorfer Institut für Physik und Medizin GmbH | 2 |
Showing 12 of 61. All products under Stimulator, Nerve, Peripheral, Electric
510(K) Clearances
| 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.