FDA Registration
Active
🇺🇸 United States
Slow Wave, Inc.
Reg #: 3017520337
·
FEI: 3017520337
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Slow Wave, Inc.
- Registration Number
- 3017520337
- FEI Number
- 3017520337
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 22111 Tx Hwy 71 W Ste 104
- City
- Spicewood
- State
- TX
- ZIP
- 78669
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240463
Owner / Operator
- Firm Name
- Slow Wave, Inc.
- Operator Number
- 10078388
- Address
- 26100 Countryside Dr.
- City
- Spicewood
- State
- TX
- Postal Code
- 78669
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthguard, Migraine/Tension Headache | OCO | Class U | Unknown | No | 2024-08-22 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-08-22 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2020-10-20 |
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2020-10-20 |
Proprietary Names
DS8
BROSA
Slow Wave DS8
Establishment Types
Manufacture Medical Device