FDA Registration
Active
🇺🇸 United States
ORTHOMED, LLC
Reg #: 3009142693
·
FEI: 3009142693
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- ORTHOMED, LLC
- Registration Number
- 3009142693
- FEI Number
- 3009142693
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9925 Painter Ave, Suite D
- City
- Whittier
- State
- CA
- ZIP
- 90605
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993420
Owner / Operator
- Firm Name
- Orthomed, LLC
- Operator Number
- 10036783
- Address
- 9925 Painter Ave Ste D
- City
- Whittier
- State
- CA
- Postal Code
- 90605
- Country
- US
- Correspondent
- Renee M Smedley-Gonzalez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2011-05-25 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2011-05-25 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-02-05 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2019-07-02 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-04-14 |
Proprietary Names
myHome Rehab Exercise Kit
Tri-Wave
OrthoTHERM Smart Heating Pad
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device