FDA Registration
Active
🇺🇸 United States
SmartVest Clearway
Reg #: 2134852
·
FEI: 3003007907
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ELECTROMED, INC.
- Registration Number
- 2134852
- FEI Number
- 3003007907
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 502 SIXTH AVE. N.W.
- City
- NEW PRAGUE
- State
- MN
- ZIP
- 56071
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222496
Owner / Operator
- Firm Name
- ELECTROMED, INC.
- Operator Number
- 9034783
- Address
- 502 SIXTH AVE., NW, --
- City
- New Prague
- State
- MN
- Postal Code
- 56071
- Country
- US
- Correspondent
- Amy Yanta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2023-01-04 |
Proprietary Names
SmartVest Clearway
SmartVest
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device