Spes Medica Subdermal Needle Electrodes
Spes Medica Subdermal Needle Electrodes record biopotential signals with compatible recording, monitoring and stimulation equipment. They are monopolar electrodes used for signals such as…
Spes Medica Subdermal Needle Electrodes record biopotential signals with compatible recording, monitoring and stimulation equipment. They are monopolar electrodes used for signals such as EMG, EEG and nerve potentials.
A stainless steel needle connects to a lead wire ending in a safety connector. The electrodes can also provide microstimulation to activate an electrical response; that stimulation has no therapeutic purpose. They are supplied sterile for single-patient use.
Needle and Lead Options
Needle lengths span 7 to 22 mm, with 0.4 or 0.6 mm diameters. Lead-wire lengths include 1.0, 1.5 and 2.5 m. The tinned-copper lead has a PVC jacket, and its DIN 42802 safety connector is designed so it cannot connect to an AC power outlet.
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (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 |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Spes Medica Srl, Italy |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| 510(k) | K192603 |
| Record published | 2020-01-28 |
| Record revised | 2025-02-21 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MN4013HD15S | 24 | In distribution | |
| MN4013HD10S | 24 | In distribution | |
| TT05MN4013D/15 | 20 | In distribution | |
| TT10MN4013D/10 | 20 | In distribution | |
| MN4008D10S | 24 | In distribution | |
| MNCS0615DTS | 12 | In distribution | |
| MN4013D20A/S | 20 | In distribution | |
| MN4013D15B/S | 20 | In distribution | |
| MN4018D25S | 24 | In distribution | |
| MNCS0625DS | 24 | In distribution | |
| MN4013D10B/S | 20 | In distribution | |
| MNCS0615US | 24 | In distribution | |
| MN4008D10B | 24 | In distribution | |
| MN4013D25S | 24 | In distribution | |
| TT05MN4013D/25 | 20 | In distribution | |
| MN4008D15S | 24 | In distribution | |
| TT03MN4013D/10 | 20 | In distribution | |
| MN4013CD10S | 24 | In distribution | |
| MNCS0610US | 24 | In distribution | |
| MN4013D15S | 24 | In distribution | |
| MN4008D25B | 24 | In distribution | |
| TT10MN4013D/15 | 20 | In distribution | |
| MN4022D10S | 24 | In distribution | |
| MN4018D15A/S | 20 | In distribution | |
| TT05MN4018D/10 | 20 | In distribution | |
| TT03MN4018D/10 | 20 | In distribution | |
| MNCS0610DS | 24 | In distribution | |
| MN4022D25S | 24 | In distribution | |
| TT05MN4013D/10 | 20 | In distribution | |
| TT03MN4013D/25 | 20 | In distribution | |
| MN4018D15S | 24 | In distribution | |
| TT10MN4018D/15 | 20 | In distribution | |
| MNCS0615DT6 | 10 | In distribution | |
| MN4018D10S | 24 | In distribution | |
| MN2013D10S | 24 | In distribution | |
| MN4013CD15S | 24 | In distribution | |
| MNCS0625US | 24 | In distribution | |
| MN4008D25A/S | 20 | In distribution | |
| TT03MN4013D/15 | 20 | In distribution | |
| MN4013D10S | 24 | In distribution | |
| MN4008D10A/S | 20 | In distribution | |
| TT10MN4018D/10 | 20 | In distribution | |
| TT05MN4018D/25 | 20 | In distribution | |
| MN4022D15S | 24 | In distribution | |
| TT10MN4018D/25 | 20 | In distribution | |
| MNCS0615DT5 | 10 | In distribution | |
| MNCS0610DTS | 12 | In distribution | |
| TT03MN4018D/25 | 20 | In distribution | |
| MN4013D20B/S | 20 | In distribution | |
| MN4008D15A/S | 20 | In distribution | |
| MNCS0625DTS | 12 | In distribution | |
| MN4013D15B | 24 | In distribution | |
| MN4013D10A/S | 20 | In distribution | |
| MN4018D20A/S | 20 | In distribution | |
| MN4013CD20S | 24 | In distribution | |
| MN4013D25B | 24 | In distribution | |
| TT10MN4013D/25 | 20 | In distribution | |
| MN4008D15B | 24 | In distribution | |
| MN4013HD25S | 24 | In distribution | |
| MN4018D10A/S | 20 | In distribution | |
| TT03MN4018D/15 | 20 | In distribution | |
| MNCS0615DS | 24 | In distribution | |
| TT05MN4018D/15 | 20 | In distribution | |
| MN4013D15A/S | 20 | In distribution | |
| MN4013D10B | 24 | In distribution | |
| MN4008D25S | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
| Neurosign V4 | Technomed Engineering B.V. | 30 |
Showing 12 of 106. All products under Electrode, Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192603 | 2019-11-22 |
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.