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iGlove Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref K-GLOVE-LModel Garment Electrodes
by TensCare Ltd
Identity
- Trade Name
- iGlove Large EUDAMEDTensCare FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrode, transcutaneous, electric nerve, Garment EUDAMEDThe iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your hands, with an intended use for the desired success of any stimulation (TENS or EMS). it is intended for a single user. FDA UDI
- Model / Reference
- Garment Electrodes EUDAMEDK-GLOVE-L EUDAMEDiGlove Large FDA UDI
- Description
- The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your hands, with an intended use for the desired success of any stimulation (TENS or EMS). it is intended for a single user. FDA UDI
Identifiers
- Catalog Number
- K-GL-L FDA UDI
- Primary DI / UDI-DI
- 05033435000722 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435E00022BNL EUDAMED
- 510(k) Number
- K171721 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
- Poland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
iGlove Large by TensCare 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 | 5033435E00022BNL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 63fa4fb6-eb91-46d7-83a4-ad572564cfc2 61 fields · synced Jun 18, 2026
- FDA UDI 4a9548aa-096c-43fb-8581-c199483fd4ca 35 fields · synced May 30, 2026