TOF-S2_B
Hand sensor and electrodes connector
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.
| 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) | K172690 |
| Record published | 2020-03-20 |
| Record revised | 2023-12-18 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TOF-S2_B | 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 |
|---|---|
| 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.