Pulse
PULSE Dual Patient Reference Array Kit
8manufacturers in China registered for this device type
18catalogue numbers in this listing
6510(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 | Nuvasive, Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K210574 |
| Record published | 2023-05-02 |
| Record revised | 2025-06-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5050206 | In distribution | |
| BETPULSECAM | In distribution | |
| 5050205 | In distribution | |
| 5050310 | In distribution | |
| LNPULSELRTABLET | In distribution | |
| 50130001 | In distribution | |
| BETPULSELRGE9 | In distribution | |
| 5050402 | In distribution | |
| 1865320 | In distribution | |
| 50110201 | In distribution | |
| PULSELRBED | In distribution | |
| BETPULSEIOM | In distribution | |
| 5050125 | In distribution | |
| 5050503 | In distribution | |
| 5050130 | In distribution | |
| 1833071 | In distribution | |
| 1840172 | In distribution | |
| BETPULSENAVINSM1 | In distribution |
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 |
|---|---|
| K112717 | 2012-04-13 |
| K112718 | 2012-03-16 |
| K111597 | 2011-10-13 |
| K051718 | 2005-09-15 |
| K040543 | 2004-04-01 |
| K032083 | 2003-10-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Nuvasive, Inc. | 510(k) number | 2022-07-19 | Class III | Software design | Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures. | 7 |
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.