Identity
- Trade Name
- Myocene Electrode FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430004268017 FDA UDI
- 510(k) Number
- K132998 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, reusable
Myocene Electrode by Myocene — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132998 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Moore Medical — Moore Medical Corp.
- Moore Medical — Moore Medical Corp.
- Baxter — PRO MEDICAL SUPPLIES, INC.
- Baxter — PRO MEDICAL SUPPLIES, INC.
- Baxter — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
- EcoPatch — PRO MEDICAL SUPPLIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Myocene
Sources (1)
- FDA UDI c3e25976-ee43-4888-b449-aec217be150d 35 fields · synced Jun 1, 2026