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Ampcare E Series Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50709LT
by Ampcare, LLC
Identity
- Trade Name
- Ampcare E Series Electrodes EUDAMEDE Series FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Ampcare E Series Electrodes EUDAMEDSelf-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only. FDA UDI
- Model / Reference
- 50709LT EUDAMEDFDA UDI
- Description
- Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only. FDA UDI
Identifiers
- Catalog Number
- 50709LT FDA UDI
- Primary DI / UDI-DI
- 00867786000200 EUDAMEDFDA UDI
- Basic UDI-DI
- 0867786000250709KM EUDAMED
- 510(k) Number
- K121483 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Ampcare E Series Electrodes by Ampcare, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0867786000250709KM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ampcare, LLC
- EUDAMED SRN
- US-MF-000038602
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 85f894ed-20e3-4813-8c4c-39758ac2e9aa 61 fields · synced Jun 20, 2026
- FDA UDI 61f6969d-56ad-475f-bb2e-9d16a2c16a68 36 fields · synced May 30, 2026