FDA Registration
Active
🇩🇪 Germany
Healy GMBH
Reg #: 3016508547
·
FEI: 3016508547
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Healy GMBH
- Registration Number
- 3016508547
- FEI Number
- 3016508547
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Schloss Kraenzlin, Darritzer Strasse 6
- City
- Kraenzlin Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K191075
Owner / Operator
- Firm Name
- TimeWaver Production GmbH
- Operator Number
- 10040063
- Address
- Schloss Kraenzlin, Darritzer Strasse 6
- City
- Kraenzlin
- State
- Brandenburg
- Postal Code
- 16818
- Country
- DE
- Correspondent
- Babak Jafarian
US Agent
- Business Name
- Herrington Consulting LLC
- Contact Name
- Douglas Herrington
- Address
- 2885 Sanford Ave SW#43083
- City
- Grandville
- State
- MI
- ZIP
- 49418
- Country
- US
- [email protected]
- Phone
- 248 3695564
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2020-01-17 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2020-01-17 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-12-15 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2021-12-15 |
Proprietary Names
HEALY
TimeWaver Frequency
Establishment Types
Manufacture Medical Device