FDA Registration
Active
🇨🇦 Canada
HOMEDICS Group Canada
Reg #: 3008011951
·
FEI: 3008011951
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HOMEDICS Group Canada
- Registration Number
- 3008011951
- FEI Number
- 3008011951
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6460 Kennedy Road, Unit C
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K081160
Owner / Operator
- Firm Name
- Homedics Group Canada
- Operator Number
- 10043839
- Address
- 3000 N Pontiac Trl
- City
- Commerce Twp
- State
- MI
- Postal Code
- 48390
- Country
- US
- Correspondent
- Laura Foos
US Agent
- Business Name
- FKA Brands
- Contact Name
- Laura Foos
- Address
- 3000 N Pontiac Trl
- City
- Commerce Township
- State
- MI
- ZIP
- 48390
- Country
- US
- [email protected]
- Phone
- 734 8375066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-11-14 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2014-03-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-14 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2022-11-15 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2013-04-01 |
Establishment Types
Repack or Relabel Medical Device