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PALS Clinical
EUDAMEDFDA UDIClass I (EU MDR)
Ref 210220Model Neurostimulation Electrodes
Identity
- Trade Name
- PALS Clinical EUDAMEDFDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Neurostimulation Electrodes EUDAMED2" x 2" square FDA UDI
- Model / Reference
- Neurostimulation Electrodes EUDAMED210220 EUDAMEDFDA UDI
- Description
- 2" x 2" square FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851913006241 EUDAMEDFDA UDI
- Basic UDI-DI
- 00851913006StimWT EUDAMED
- 510(k) Number
- K132422 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
- Denmark 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
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
PALS Clinical by Axelgaard Manufacturing Co., Ltd. — 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 | 00851913006StimWT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Axelgaard Manufacturing Co., Ltd.
- EUDAMED SRN
- US-MF-000009382
- Authorised Representative
- Axelgaard Manufacturing Co., Ltd. DK-AR-000002096
Sources (2)
- EUDAMED 0d8e1a11-fb6f-4e13-b7aa-2471c7d52343 61 fields · synced Aug 3, 2026
- FDA UDI 3260b452-1f85-4094-83c2-6c60505e860c 36 fields · synced May 29, 2026