FDA Registration
Active
🇬🇧 United Kingdom
Hypoallergenic Electrode pads 50X50 mm
Reg #: 3003446042
·
FEI: 3003446042
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TENSCARE LTD.
- Registration Number
- 3003446042
- FEI Number
- 3003446042
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
- City
- EPSOM Surrey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K132588
Owner / Operator
- Firm Name
- TENSCARE LTD.
- Operator Number
- 9046089
- Address
- PAINAWAY HOUSE, 9 BLENHEIM ROAD, LONGMEAD BUSINESS PARK
- City
- EPSOM
- State
- Surrey
- Postal Code
- KT19 9BE
- Country
- GB
- Correspondent
- Saskia Eldridge-Hinmers
US Agent
- Business Name
- QA/RA Consulting Group, Inc.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Road
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2024-11-04 |
Proprietary Names
Hypoallergenic Electrode pads 50X50 mm
Carbon Mesh Electrode pads 50X100 mm
Carbon Mesh Electrode pads 50X50 mm
Cooling Electrode pads 50X100 mm
Cooling Electrode pads 50X50 mm
Establishment Types
Repack or Relabel Medical Device