Electromyograph, Diagnostic
CART FOR MEB-9400, MEB-2300, MEE-1000 and MEE-2000 desktop systems
2manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1). 2 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 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | Nihon Kohden America, Inc., United States |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-19 |
| Record revised | 2024-03-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JB-942BK | In distribution | |
| NE-430B | In distribution | |
| JB-944BK | In distribution | |
| QP-946BK | In distribution | |
| KD-019A | In distribution | |
| YZ-0172 | In distribution | |
| A/NWB-HL7CS | In distribution | |
| QP-947BK | In distribution | |
| BM-701B | In distribution | |
| KH-001A | In distribution | |
| NE-432B | In distribution | |
| QP-948BK | In distribution | |
| YE-103J | In distribution | |
| RY-441B | In distribution | |
| A/NIH9000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Electromyograph, Diagnostic | Medtronic Xomed, Inc. | 36 |
| Natus | Natus Neurology Incorporated | 21 |
| Natus Neurology | Natus Neurology Incorporated | 21 |
| NVM5 | Nuvasive, Inc. | 19 |
| Epad | Safeop Surgical, Inc. | 18 |
| Pulse | Nuvasive, Inc. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden Corp. | 16 |
| Natus | Xltek | 14 |
| Neuropack S3 | Nihon Kohden Corp. | 8 |
| Electromyograph, Diagnostic | Medtronic Sofamor Danek, Inc. | 7 |
| MyoVision Software | Precision Biometrics, Inc. | 5 |
| SafeOp | Alphatec Spine, Inc. | 4 |
Showing 12 of 49. All products under Electromyograph, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K010590 | 2001-06-28 |
| K823562 | 1983-01-14 |
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.