Stimulator, Nerve
Connecting cable S shielded f. inomed laryngeal electrodesTouchproof
8manufacturers in China registered for this device type
20catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Changzhou Emanmed Biotechnology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Inomed Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Manufacturer |
| Record published | 2016-08-31 |
| Record revised | 2026-06-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-06-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5140-530-856 | In distribution | ||
| 533666 | 10 | In distribution | |
| 520855 | 10 | In distribution | |
| 520856 | 10 | In distribution | |
| 5140-530-855 | In distribution | ||
| 530663 | Withdrawn | ||
| 530667 | Withdrawn | ||
| 5140-530-656 | Withdrawn | ||
| 532637 | Withdrawn | ||
| 530665 | Withdrawn | ||
| 530866 | Withdrawn | ||
| 530656 | Withdrawn | ||
| 530855 | Withdrawn | ||
| 530869 | Withdrawn | ||
| 530856 | Withdrawn | ||
| 508281 | Withdrawn | ||
| 5140-530-655 | Withdrawn | ||
| 530655 | Withdrawn | ||
| 508241 | Withdrawn | ||
| 530867 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 226 |
| Stimulator, Nerve | Medtronic Xomed, Inc. | 125 |
| MaXcess | Nuvasive, Inc. | 95 |
| Armada | Nuvasive, Inc. | 67 |
| Stimulator, Nerve | Neurovision Medical Products, Inc. | 47 |
| Precept | Nuvasive, Inc. | 39 |
| MAS Plif | Nuvasive, Inc. | 36 |
| NIM | Medtronic Xomed, Inc. | 34 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242852 | 2025-06-13 |
| K223254 | 2023-01-27 |
| K212164 | 2022-11-11 |
| K152505 | 2016-02-01 |
| K091874 | 2009-11-18 |
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.