Rhythmlink®
17 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector and 1 template, color-coded original BraiNet
4manufacturers in China registered for this device type
204catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Rhythmlink International, LLC, United States |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-10-31 |
| Record revised | 2019-09-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 10 to 40 °C |
| Packaging | Product box of 10, product box of 24, product box of 12, product box of 3, product box of 6, product box of 20 |
| Sizes | Length 7 to 22 mm; outer diameter 0.6 mm; needle gauge 28 G |
| Distribution end date | 2026-06-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RLSP531C | In distribution | ||
| RLSP554 | In distribution | ||
| RLSP555 | In distribution | ||
| RLSND125-2.5 | Length 7 mm | In distribution | |
| RLSND832-2.5 | Length 13 mm | In distribution | |
| CTGN615 | In distribution | ||
| GNFD515 | In distribution | ||
| RLSP542 | In distribution | ||
| RLSND108-1.5 | Length 7 mm | In distribution | |
| TCN2125 | In distribution | ||
| RLSND170-2.5 | Length 22 mm | In distribution | |
| RLSND173-1.5 | Length 22 mm | In distribution | |
| RLSND820-2.5 | Length 13 mm | In distribution | |
| CTGN115 | In distribution | ||
| RLSP310 | Length 13 mm | In distribution | |
| RLSND114-2.5 | Length 19 mm | In distribution | |
| RLSND827-1.5 | Length 13 mm | In distribution | |
| RLSND126-2.5 | Length 7 mm | In distribution | |
| RLSND505-1.5 | Length 13 mm | In distribution | |
| RLSND815-2.5 | Length 13 mm | In distribution | |
| RLSP503 | Length 13 mm | In distribution | |
| RLSND125-1.5 | Length 7 mm | In distribution | |
| MRP310 | In distribution | ||
| RLSND512-1.5 | Length 13 mm | In distribution | |
| RLSND830-2.5 | Length 13 mm | In distribution | |
| RLSND501-2.5 | Length 13 mm | In distribution | |
| RLSND501-1.5 | Length 13 mm | In distribution | |
| RLSP483 | Length 13 mm | In distribution | |
| RLSND112-2.5 | Length 13 mm | In distribution | |
| RLSND823-1.5 | Length 13 mm | In distribution | |
| RLSND505-1.0 | Length 13 mm | In distribution | |
| RLSND831-1.5 | Length 13 mm | In distribution | |
| RLSND121-2.0 | Length 13 mm | In distribution | |
| RLSND109-2.5 | Length 7 mm | In distribution | |
| RLSND506-1.5 | Length 13 mm | In distribution | |
| RLSP538 | In distribution | ||
| TSN2320 | In distribution | ||
| RLSND819-2.5 | Length 13 mm | In distribution | |
| TCN4115 | In distribution | ||
| RLSND122-2.5 | Length 13 mm | In distribution | |
| RLSND818-2.5 | Length 13 mm | In distribution | |
| MRP410 | In distribution | ||
| RLSND116P-1.5 | Length 13 mm | In distribution | |
| RLSP552 | In distribution | ||
| RLSND833-1.5 | Length 13 mm | In distribution | |
| RLSP543 | In distribution | ||
| RLSP527 | In distribution | ||
| RLSND107-1.5 | Length 7 mm | In distribution | |
| CTGN2121-1.5 | In distribution | ||
| RLSND502-2.5 | Length 13 mm | In distribution | |
| RLSND506-1.0 | Length 13 mm | In distribution | |
| RLSND506-2.5 | Length 13 mm | In distribution | |
| RLSND512-2.5 | Length 13 mm | In distribution | |
| CTGN2121-2.5 | In distribution | ||
| RLSP486 | Outer Diameter.6 mm | In distribution | |
| MRP525 | In distribution | ||
| RLSP556 | In distribution | ||
| RLSND132-2.5 | Length 13 mm | In distribution | |
| MRP225 | In distribution | ||
| TSN2325 | In distribution | ||
| RLSP504 | Length 22 mm | In distribution | |
| RLSND833-2.5 | Length 13 mm | In distribution | |
| RLSND829-2.5 | Length 13 mm | In distribution | |
| RLSP350 | Length 13 mm | In distribution | |
| RLSND511-2.5 | Length 13 mm | In distribution | |
| RLSND110-1.5 | Length 13 mm | In distribution | |
| RLSND121-1.0 | Length 13 mm | In distribution | |
| RLSND824-2.5 | Length 13 mm | In distribution | |
| RLSP527C | Length 13 mm | In distribution | |
| RLSND817-1.5 | Length 13 mm | In distribution | |
| RLSP484 | Length 13 mm | In distribution | |
| MRP515 | In distribution | ||
| RLSND508-1.5 | Length 13 mm | In distribution | |
| RLSND170-1.5 | Length 22 mm | In distribution | |
| RLSND832-1.5 | Length 13 mm | In distribution | |
| RLSND123-1.5 | Length 19 mm | In distribution | |
| TCN4125 | In distribution | ||
| RLITN1415 | In distribution | ||
| RLSND505-2.5 | Length 13 mm | In distribution | |
| RLSND140-2.5 | Outer Diameter.6 mm | In distribution | |
| RLSND113-2.5 | Length 19 mm | In distribution | |
| RLSND116-1.5 | Length 13 mm | In distribution | |
| RLSND823-2.5 | Length 13 mm | In distribution | |
| 112-812-60TP | Needle Gauge 28 G | In distribution | |
| RLSND818-1.5 | Length 13 mm | In distribution | |
| RLSND121-1.5 | Length 13 mm | In distribution | |
| RLSND117-1.5 | Length 13 mm | In distribution | |
| RLSP544 | In distribution | ||
| RLSND825-2.5 | Length 13 mm | In distribution | |
| RLSND511-1.5 | Length 13 mm | In distribution | |
| CTGN121-2.5 | In distribution | ||
| RLSND509-2.5 | Length 13 mm | In distribution | |
| CTN115 | Length 13 mm | In distribution | |
| CTGN215 | In distribution | ||
| RLSND111-1.5 | Length 13 mm | In distribution | |
| RLSND109-1.5 | Length 7 mm | In distribution | |
| DHP102121 | In distribution | ||
| RLITN1515 | In distribution | ||
| MRP315 | In distribution | ||
| RLSND122-1.0 | Length 13 mm | In distribution | |
| RLSND131-2.5 | Length 13 mm | In distribution | |
| RLSND830-1.5 | Length 13 mm | In distribution | |
| RLSND510-2.5 | Length 13 mm | In distribution | |
| PB115 | In distribution | ||
| RLSND822-2.5 | Length 13 mm | In distribution | |
| CTPB115 | In distribution | ||
| RLSND174-2.5 | Length 22 mm | In distribution | |
| RLSND108-2.5 | Length 7 mm | In distribution | |
| MRP415 | In distribution | ||
| RLSP529 | 2 | In distribution | |
| RLSND111-1.0 | Length 13 mm | In distribution | |
| RLSND821-2.5 | Length 13 mm | In distribution | |
| RLSP539 | 6 | In distribution | |
| RLSND828-2.5 | Length 13 mm | In distribution | |
| RLSP522 | 6 | In distribution | |
| RLSND501-1.0 | Length 13 mm | In distribution | |
| RLSND118-1.5 | Length 13 mm | In distribution | |
| SN15G | In distribution | ||
| RLSND824-1.5 | Length 13 mm | In distribution | |
| RLSND111-2.5 | Length 13 mm | In distribution | |
| MRP325 | In distribution | ||
| RLSND504-1.5 | Length 13 mm | In distribution | |
| RLSND508-2.5 | Length 13 mm | In distribution | |
| RLSND814-1.5 | Length 13 mm | In distribution | |
| RLSND509-1.5 | Length 13 mm | In distribution | |
| RLSND124-2.5 | Length 19 mm | In distribution | |
| RLSP530 | In distribution | ||
| RLSND828-1.5 | Length 13 mm | In distribution | |
| RLSND111-2.5C | Length 13 mm | In distribution | |
| RLSP546 | In distribution | ||
| RLSND502-1.5 | Length 13 mm | In distribution | |
| MRP210 | In distribution | ||
| RLSND801-2.5 | Length 13 mm | In distribution | |
| RLSND122-1.5 | Length 13 mm | In distribution | |
| GNFD5152 | In distribution | ||
| RLSND504-2.5 | Length 13 mm | In distribution | |
| RLSND826-2.5 | Length 13 mm | In distribution | |
| RLSND817-2.5 | Length 13 mm | In distribution | |
| RLSND174-1.5 | Length 22 mm | In distribution | |
| RLSND140-1.0 | Outer Diameter.6 mm | In distribution | |
| TCN5125 | In distribution | ||
| RLSND173-2.5 | Length 22 mm | In distribution | |
| RLSND821-1.5 | Length 13 mm | In distribution | |
| RLSND314-2.5 | Length 13 mm | 7 | In distribution |
| SNB1710 | In distribution | ||
| RLSP553 | In distribution | ||
| RLSND825-1.5 | Length 13 mm | In distribution | |
| RLSND123-2.5 | Length 19 mm | In distribution | |
| CTN125 | Length 13 mm | In distribution | |
| RLSND827-2.5 | Length 13 mm | In distribution | |
| RLSP477 | Length 13 mm | In distribution | |
| RLSND829-1.5 | Length 13 mm | In distribution | |
| TCN2115 | In distribution | ||
| RLSND822-1.5 | Length 13 mm | In distribution | |
| RLSND124-1.5 | Length 19 mm | In distribution | |
| MRPB215 | In distribution | ||
| RLSND802-2.5 | Length 13 mm | In distribution | |
| RLSND126-1.5 | Length 7 mm | In distribution | |
| CTGN121-1.5 | In distribution | ||
| MRP215 | In distribution | ||
| RLSND507-1.5 | Length 13 mm | In distribution | |
| RLSND820-1.5 | Length 13 mm | In distribution | |
| RLSND815-1.5 | Length 13 mm | In distribution | |
| RLSND831-2.5 | Length 13 mm | In distribution | |
| RLSND816-1.5 | Length 13 mm | In distribution | |
| CTGN2121-2.5 | In distribution | ||
| RLSP351 | Length 13 mm | In distribution | |
| RLSP545 | In distribution | ||
| RLSP532 | In distribution | ||
| RLSND140-1.5 | Outer Diameter.6 mm | In distribution | |
| RLSND503-2.5 | Length 13 mm | In distribution | |
| TCN5115 | In distribution | ||
| RLSND826-1.5 | Length 13 mm | In distribution | |
| RLSND507-2.5 | Length 13 mm | In distribution | |
| RLSND814-2.5 | Length 13 mm | In distribution | |
| RLSND113-1.5 | Length 19 mm | In distribution | |
| RLSND503-1.5 | Length 13 mm | In distribution | |
| RLSP512 | In distribution | ||
| RLSND819-1.5 | Length 13 mm | In distribution | |
| RLSND107-2.5 | Length 7 mm | In distribution | |
| RLSND110-2.5 | Length 13 mm | In distribution | |
| SN15W | In distribution | ||
| RLSND121-2.5 | Length 13 mm | In distribution | |
| RLSP513 | In distribution | ||
| RLSND110-1.0 | Length 13 mm | In distribution | |
| RLSND116-2.5 | Length 13 mm | In distribution | |
| RLSND114-1.5 | Length 19 mm | In distribution | |
| RLSND510-1.5 | Length 13 mm | In distribution | |
| RLSP450 | Length 13 mm | In distribution | |
| RLSP430 | Length 13 mm | In distribution | |
| RLSND816-2.5 | Length 13 mm | In distribution | |
| RLSP515 | Withdrawn | ||
| BNT100-1.0 | Withdrawn | ||
| BNT110-STD-5462 | Withdrawn | ||
| BNT110-STD-4554 | Withdrawn | ||
| CTP115 | Withdrawn | ||
| RLSP520 | 2 | Withdrawn | |
| RLSP514 | Withdrawn | ||
| MRP510 | Withdrawn | ||
| RLSP320 | Length 13 mm | Withdrawn | |
| RLSP522 | 6 | Withdrawn | |
| RLSP523 | Withdrawn | ||
| P115 | Withdrawn | ||
| MRP425 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200984 | 2020-05-27 |
| K190801 | 2019-07-10 |
| K130220 | 2013-07-22 |
| K121347 | 2012-07-12 |
| K022914 | 2002-12-20 |
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.