FDA Registration
Active
🇺🇸 United States
Health Monitoring smartwatch Empatica
Reg #: 3012302888
·
FEI: 3012302888
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- QUIPMENT INC.
- Registration Number
- 3012302888
- FEI Number
- 3012302888
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1640 Airport Road, Suite 105
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221282
Owner / Operator
- Firm Name
- Quipment Inc
- Operator Number
- 10062070
- Address
- 1640 Airport Rd NW Suite 105
- City
- Kennesaw
- State
- GA
- Postal Code
- 30144
- Country
- US
- Correspondent
- Didier Justel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Sleep Assessment | LEL | Class 2 | Neurology | No | 2025-03-24 |
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2025-03-24 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-03-24 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2025-03-24 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-03-24 |
Proprietary Names
Health Monitoring smartwatch Empatica
Establishment Types
Repack or Relabel Medical Device