FDA Registration
Active
🇪🇸 Spain
TERMOSALUD S.L.
Reg #: 3026400760
·
FEI: 3026400760
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- TERMOSALUD S.L.
- Registration Number
- 3026400760
- FEI Number
- 3026400760
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ataulfo Friera Tarfe 8
- City
- Gijon Asturias
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K243716
Owner / Operator
- Firm Name
- Termosalud S.L.
- Operator Number
- 10087295
- Address
- Ataulfo Friera Tarfe 8
- City
- Gijón
- State
- Asturias
- Postal Code
- 33211
- Country
- ES
- Correspondent
- Veronica Rodriguez Rojas
US Agent
- Business Name
- Hoy & Associates Regulatory Consulting, LLC
- Contact Name
- Connie Hoy
- Address
- 1830 Bonnie Way
- City
- sacramento
- State
- CA
- ZIP
- 95825
- Country
- US
- [email protected]
- Phone
- 530 9084903
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2026-04-28 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-04-09 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2026-04-28 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2023-02-09 |
Proprietary Names
Z-CAP ZIONIC PRO MAX HP
ZIONIC PRO MAX
Z-RES ZIONIC PRO MAX HP
ENEKA PRO
ZIONIC AESTHETIC
SYMMED ELITE AESTHETIC
VMAT PRO
Z-EMS
MASSAGE & O2XY
ENEKA SELECTIF
DEEP2
Establishment Types
Manufacture Medical Device