Electromyograph, Diagnostic
Electrode 8227422 Twist Pair ST 8CH Rohs
2manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K024316 |
| Record published | 2016-04-07 |
| Record revised | 2024-03-07 (version 6) |
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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Pack of 10 |
| Sizes | Length 1 to 25 mm; length 2 m; length 23 cm; outer diameter 1 mm |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8227422 | In distribution | ||
| 8227703 | Length 22.0 mm | In distribution | |
| 8225715 | Length 23.0 cm | In distribution | |
| 8225490E | Length 1.0 mm | In distribution | |
| 8225490 | Length 1.0 mm | 3 | In distribution |
| 8227412 | In distribution | ||
| 8225751 | Length 2.3 mm | In distribution | |
| 8225715 | Length 23.0 cm | In distribution | |
| 8227103 | Length 12.0 mm | In distribution | |
| 8227422 | In distribution | ||
| 8225715 | Length 23.0 cm | In distribution | |
| 8227103 | In distribution | ||
| 8227505 | Length 25.0 mm | In distribution | |
| 8227450 | 5 | In distribution | |
| 8227421 | In distribution | ||
| 8227421 | In distribution | ||
| 8227500 | In distribution | ||
| 9626340 | 10 | In distribution | |
| 9626340 | 10 | In distribution | |
| 9626340 | In distribution | ||
| 8225490 | Outer Diameter 1.0 mm | 3 | In distribution |
| 8227500 | Length 2.0 m | In distribution | |
| 8227412 | In distribution | ||
| 8227422 | In distribution | ||
| 8227505 | Length 25.0 mm | Withdrawn | |
| 9626340 | 10 | Withdrawn | |
| 8227412 | Withdrawn | ||
| 8225490E | Length 1.0 mm | Withdrawn | |
| 8225490 | Length 1.0 mm | 3 | Withdrawn |
| 8227103 | Length 12.0 mm | Withdrawn | |
| 8227412 | Withdrawn | ||
| 8227500 | Length 2.0 m | Withdrawn | |
| 8227510 | 5 | Withdrawn | |
| 8227515 | 5 | Withdrawn | |
| 8227421 | Withdrawn | ||
| 8225490E | Outer Diameter 1.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Electromyograph, Diagnostic | Nihon Kohden America, Inc. | 15 |
| 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 |
|---|---|
| K024316 | 2003-01-06 |
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.