FDA Registration
Active
🇺🇸 United States
Hinge Health Inc.
Reg #: 3016856381
·
FEI: 3012640203
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Hinge Health Inc.
- Registration Number
- 3016856381
- FEI Number
- 3012640203
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 455 Market Street, Suite 700
- City
- San Francisco
- State
- CA
- ZIP
- 94105
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160052
Owner / Operator
- Firm Name
- Hinge Health Inc.
- Operator Number
- 10082971
- Address
- 455 Market Street, Suite 700
- City
- San Francisco
- State
- CA
- Postal Code
- 94105
- Country
- US
- Correspondent
- Charles Han
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-10-18 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-10-18 |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | Class 2 | Neurology | No | 2026-04-20 |
Proprietary Names
ENSO
Enso
Enso for Migraine
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198