TOF3D – Neuromuscular Transmission Monitor
The TOF3D monitors neuromuscular transmission by electrically stimulating a peripheral nerve and measuring the resulting muscle contraction. It uses acceleromyography to record the evoked…
The TOF3D monitors neuromuscular transmission by electrically stimulating a peripheral nerve and measuring the resulting muscle contraction. It uses acceleromyography to record the evoked movement and presents the results on its LCD for qualified medical staff during surgery or intensive care.
Measurements can be taken at nerve and muscle pairs such as the ulnar nerve and thumb muscle, posterior tibial nerve and foot muscle, or facial nerve and muscle around the eye. The device is intended for patients older than 18 years, including adults.
Stimulation Modes
The TOF3D supports train-of-four, post-tetanic count, double-burst and tetanic stimulation, along with 1 Hz and 0.1 Hz patterns. It can also provide peripheral nerve stimulation for subjective monitoring without its objective muscle-response measurement function.
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 | Mipm Mammendorfer Institut für Physik und Medizin GmbH, Germany |
|---|---|
| FDA product code | KOI |
| Device type | Stimulator, Nerve, Peripheral, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| 510(k) | K212434 |
| Record published | 2023-07-10 |
| Record revised | 2026-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2510091 | In distribution | |
| 2510091 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K250887 | 2025-10-21 |
| K212434 | 2022-05-05 |
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.