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Ampcare E Series Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50709ST-1Model 50709LTRef 50709STRef 50709LT-1
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 in. x 1.25 in. and are single patient use only. FDA UDI
- Model / Reference
- 50709LT EUDAMED50709ST-1 EUDAMED50709ST EUDAMEDFDA UDI50709LT-1 EUDAMED
- 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 in. x 1.25 in. and are single patient use only. FDA UDI
Identifiers
- Catalog Number
- 50709ST FDA UDI
- Primary DI / UDI-DI
- 10867786000214 EUDAMED00867786000217 EUDAMEDFDA UDI10867786000207 EUDAMED
- 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 (4)
- EUDAMED 2e2d306a-da34-4f9c-b6dc-5a22643bb01f 61 fields · synced Jul 24, 2026
- EUDAMED 22b9dde3-d3fd-4a61-9766-9dd0cb2e5be1 61 fields · synced May 17, 2026
- EUDAMED 8c6bc2cc-00c0-4ed8-a6ec-7823d55ca26a 61 fields · synced May 18, 2026
- FDA UDI 718cb575-d20d-4d7b-b02f-9c95a7947ebd 36 fields · synced May 30, 2026