Horizon™
Disposable Horizon Subdermal Needle Electrodes: 27 GA., 12 MM Bent Needle, 2.5 M Ribbon Leadwire (5-LEAD), Color Group SP1
4manufacturers in China registered for this device type
68catalogue numbers in this listing
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 | Rochester Electro Medical, Inc., United States |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-08-08 (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 |
| Packaging | Pack of 20, pack of 10, pack of 24, pack of 50, pack of 25 |
| Distribution end date | 2019-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S86015-R1 | Withdrawn | |
| S02244-90-I | Withdrawn | |
| S83015-PL1-20 | Withdrawn | |
| S85015-T5 | Withdrawn | |
| S83015-PL2-10 | Withdrawn | |
| S91072 | Withdrawn | |
| S91690-50/PK | Withdrawn | |
| S81015-A-24 | Withdrawn | |
| S82015-PT2-20 | Withdrawn | |
| S85015-R5 | Withdrawn | |
| S94015-A-24 | Withdrawn | |
| S95325-RHSP1 | Withdrawn | |
| S82025-PT1-10 | Withdrawn | |
| S86025-R1 | Withdrawn | |
| S82015-PT1-20 | Withdrawn | |
| S85015-RSP1 | Withdrawn | |
| S82925-PT3-20 | Withdrawn | |
| S01114-PS | Withdrawn | |
| S82025-PT2-10 | Withdrawn | |
| S86015-T1 | Withdrawn | |
| S80025-R10B | Withdrawn | |
| S95315-R5H | Withdrawn | |
| S92690-PT1-20 | Withdrawn | |
| S80025-R10W | Withdrawn | |
| S82015-PT3-20 | Withdrawn | |
| S83025-PL1-20 | Withdrawn | |
| S96315-R1H | Withdrawn | |
| S94415-PT2-20 | Withdrawn | |
| S82615-PT1-20 | Withdrawn | |
| S91090-C-20 | Withdrawn | |
| S83025-PL2-20 | Withdrawn | |
| S81915-A-24 | Withdrawn | |
| S83018-R9 | Withdrawn | |
| S81015-C-20 | Withdrawn | |
| S94425-PT1-20 | Withdrawn | |
| S83025-PL3-20 | Withdrawn | |
| S82020-PT1-20 | Withdrawn | |
| S82025-PT2-20 | Withdrawn | |
| S82025-PT1-20 | Withdrawn | |
| S92090-P | Withdrawn | |
| S87025-RSP2 | Withdrawn | |
| S87025-RHSP2 | Withdrawn | |
| S81025-A-24 | Withdrawn | |
| S01115-PS | Withdrawn | |
| S91090-50 | Withdrawn | |
| S96072-R | Withdrawn | |
| S86020-R1 | Withdrawn | |
| S92090-P1-10 | Withdrawn | |
| S82215-PT3-20 | Withdrawn | |
| S95315-RHSP1 | Withdrawn | |
| S82215-PT1-10 | Withdrawn | |
| S87015-RSP2 | Withdrawn | |
| S86025-T1 | Withdrawn | |
| S03344 | Withdrawn | |
| S81025-C-20 | Withdrawn | |
| S94425-PT2-20 | Withdrawn | |
| S91615-A-24 | Withdrawn | |
| S88015-R2 | Withdrawn | |
| S94090-H | Withdrawn | |
| S012415 | Withdrawn | |
| S86615-R1 | Withdrawn | |
| S85025-T5 | Withdrawn | |
| S83021-R10 | Withdrawn | |
| S87015-RHSP2 | Withdrawn | |
| S82025-PT3-20 | Withdrawn | |
| S82225-PT3-20 | Withdrawn | |
| S96090-R1 | Withdrawn | |
| S92090-PT3-20 | Withdrawn |
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 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| 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
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.