FDA Registration
Active
🇺🇸 United States
MYOMO, INC.
Reg #: 3006240003
·
FEI: 3006240003
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MYOMO, INC.
- Registration Number
- 3006240003
- FEI Number
- 3006240003
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 45 Blue Sky Dr Ste 101
- City
- Burlington
- State
- MA
- ZIP
- 01803
- Country
- US
Owner / Operator
- Firm Name
- MYOMO, INC.
- Operator Number
- 9100960
- Address
- 45 Blue Sky Drive, Suite 101
- City
- Burlington
- State
- MA
- Postal Code
- 01803
- Country
- US
- Correspondent
- Dennis - Shay
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2016-12-19 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2009-05-27 |
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2012-11-01 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2009-08-06 |
Proprietary Names
MyoPro
MARK
MyoPro 2+
MARK2
MyoPro 2x
MyoPro Fabrication Kit
Establishment Types
Manufacture Medical Device