Jiajian Self-Adhesive Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Self-adhesive Electrode EUDAMED
- Device Name
- Transcutaneous Electrical Nerve Stimulator EUDAMEDSelf-adhesive Electrode EUDAMED
- Model / Reference
- TENS Eco 2, TENS Eco, URO stim2, TENStem eco basic, TENS WMPS2-1,neurotech OmniTens XP+, neurotech PolyStim XP+, neurotech AvivaTens Plus EUDAMEDDX00008 EUDAMEDRound, Rectangle, Elliptical, Calabash, Butterfly, Rhombus, Saddle shape, Meniscus shape, Palm shape, Throat shape EUDAMEDNK00098 EUDAMEDDX00025 EUDAMEDDX00017 EUDAMEDNK00005 EUDAMEDDX00100 EUDAMEDDX00010 EUDAMEDDX00011 EUDAMEDDX00018 EUDAMEDNK00018 EUDAMEDNK00049 EUDAMEDNK00080 EUDAMEDDX00098 EUDAMEDDX00049 EUDAMEDDX00019 EUDAMEDNK00011 EUDAMEDDX00003 EUDAMEDDX00004 EUDAMEDNK00019 EUDAMEDNK00003 EUDAMEDNK00025 EUDAMEDDX00013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972011716727 EUDAMED06972011716895 EUDAMED06932307410180 EUDAMED06972011716819 EUDAMED06972011716918 EUDAMED06972011716703 EUDAMED06972011716758 EUDAMED06972011716765 EUDAMED06932307410173 EUDAMED06972011716970 EUDAMED06972011716932 EUDAMED06972011719926 EUDAMED06972011716673 EUDAMED06972011716741 EUDAMED06972011716833 EUDAMED06972011716949 EUDAMED06972011716666 EUDAMED06972011716680 EUDAMED06972011716987 EUDAMED06972011716888 EUDAMED06972011716994 EUDAMED06972011716772 EUDAMED
- Basic UDI-DI
- 697201171B2000001GS EUDAMED697201171A0000001F5 EUDAMED
- 510(k) Number
- K192568 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Market of Registration
- Romania EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Jiajian Self-Adhesive Electrode is a reusable adhesive electrode designed for neurological applications, classified under product code GXY. It features a flexible, conformable design to fit various body contours and incorporates a long-lasting conductive gel for consistent electrical signal transmission during procedures such as electrotherapy or electrodiagnostic testing.
Supplied as a reusable device, the Jiajian Self-Adhesive Electrode is intended for repeated use with proper cleaning and maintenance. It has received FDA 510(k) clearance under a Special review process, classified as Substantially Equivalent by the Neurology Advisory Committee. The device adheres securely to the skin without requiring additional fixation, ensuring reliable contact for extended procedures.
Frequently asked questions
Are these electrodes meant for single-use or can they be reused after proper cleaning and maintenance?
The Jiajian Self-Adhesive Electrode is explicitly designed for reusable use. The manufacturer states it can be used repeatedly with proper cleaning and maintenance, ensuring reliable performance over multiple procedures. This is supported by its classification as a reusable device in the product description.
How do these electrodes stay securely attached during procedures, and do they require additional fixation?
The electrodes feature a self-adhesive design, allowing them to adhere securely to the skin without needing extra fixation methods. This ensures consistent contact for extended use during procedures like electrotherapy or electrodiagnostic testing, as described in the product details.
What types of procedures are these electrodes intended for, and why are they classified under product code GXY?
These electrodes are designed for neurological applications, specifically for procedures like electrotherapy or electrodiagnostic testing. The classification under product code GXY (as noted in the data) aligns with their use in neurological monitoring or stimulation, though the code itself is an administrative categorization, not an indication.
What regulatory pathway did the Jiajian Self-Adhesive Electrode follow for FDA clearance, and what does that mean for its approval status?
The device received FDA 510(k) clearance through a Special review process and was determined to be Substantially Equivalent (SESE) by the Neurology Advisory Committee (NE). This means the FDA concluded it has the same intended use and technological characteristics as a legally marketed predicate device, ensuring compliance with regulatory standards for neurological electrodes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Self-Adhesive Eelectrodes - Wuxi Jiajian Medical Instrument Co.,Ltd., Self-Adhesive Electrode - 2026 Self-Adhesive Electrode, Electrode price ..., Self-adhesive Electrodes-无锡佳健医疗器械股份有限公司, Acupuncture Needles Manufacturer | Jiajianmedical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192568 | Class II | Active |
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Manufacturer
- Manufacturer
- Wuxi Jiajian Medical Instrument Co., Ltd.
Sources (23)
- FDA 510(k) K192568 24 fields · synced Oct 6, 2026
- EUDAMED 646cdceb-569b-41a0-b1bb-8832019d409f 61 fields · synced Jun 20, 2026
- EUDAMED 8b41ec38-788d-4385-8083-92b22b6a5245 61 fields · synced Jul 8, 2026
- EUDAMED 19d9ac78-e75b-40f2-9d6a-fd66234fb6fe 61 fields · synced Jul 9, 2026
- EUDAMED 4eef27de-068c-4963-ab59-5131c3cd315a 61 fields · synced Jul 10, 2026
- EUDAMED 1d3e4413-0f9a-4bf8-8735-3a15dd4ce074 61 fields · synced Jul 11, 2026
- EUDAMED 6e21b76d-0271-4ff4-8869-f014a45f99a6 61 fields · synced Jul 11, 2026
- EUDAMED d83dbe5d-026d-4cf9-bdcd-4758442dc068 61 fields · synced Jul 11, 2026
- EUDAMED 7c946feb-9844-4e15-af8d-49d6cca4047e 61 fields · synced Jul 12, 2026
- EUDAMED ebb97fb4-c37f-4bb2-a4bd-0bbd2f86b7d5 61 fields · synced Jul 12, 2026
- EUDAMED 289445c8-55fa-43aa-84e1-739c48a39b2c 61 fields · synced Jul 14, 2026
- EUDAMED 8272686e-1115-4e91-b366-e96c2b81f5a1 61 fields · synced Jul 17, 2026
- EUDAMED fd844557-0c95-4782-b392-ae5f7e4c44d9 61 fields · synced Jul 17, 2026
- EUDAMED 552c1a6f-1487-4d02-8d5e-236bb168dc30 61 fields · synced Jul 17, 2026
- EUDAMED c91a8de5-3371-4115-844f-83f8d9565b92 61 fields · synced Jul 17, 2026
- EUDAMED 8930ab7f-c57f-466e-9e97-edfd54398af6 61 fields · synced Jul 17, 2026
- EUDAMED c5159fbb-b4e2-407a-85da-0e6a8287fe90 61 fields · synced Jul 19, 2026
- EUDAMED b3e8a9da-ed18-4f2c-a993-fadda7fa38c4 61 fields · synced Jul 23, 2026
- EUDAMED be9b0c6a-babe-448e-9096-d4979c7e2a3e 61 fields · synced Jul 25, 2026
- EUDAMED b1207d2f-921d-4cf5-bf42-9c8fd0c08a11 61 fields · synced Jul 26, 2026
- EUDAMED aff2d732-893c-4d6a-8821-e20320eb0a3a 61 fields · synced Jul 28, 2026
- EUDAMED b166979a-413b-4475-91ac-0125fbaf91b0 61 fields · synced Jul 31, 2026
- EUDAMED 6f9715bd-471d-4e99-a2e6-c00a98f1bd09 61 fields · synced Aug 2, 2026