FDA Registration
Active
🇬🇧 United Kingdom
Digitimer DS7AP Constant Current Stimulator
Reg #: 3003631667
·
FEI: 3003631667
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DIGITIMER LTD.
- Registration Number
- 3003631667
- FEI Number
- 3003631667
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 37 HYDEWAY
- City
- Welwyn Garden City Hertfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K172381
Owner / Operator
- Firm Name
- DIGITIMER LTD.
- Operator Number
- 9043315
- Address
- 37 HYDEWAY, WELWYN GARDEN CITY
- City
- HERTFORDSHIRE
- State
- GB-NOTA
- Postal Code
- AL7 3BE
- Country
- GB
US Agent
- Business Name
- Digitimer North America, LLC
- Contact Name
- Steven Valenti
- Address
- 1 E Broward Blvd Ste 700
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33301
- Country
- US
- [email protected]
- Phone
- 954 3341070
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2018-09-12 |
Proprietary Names
Digitimer DS7AP Constant Current Stimulator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device