FDA Registration
Active
🇺🇸 United States
MEDHAB, LLC
Reg #: 3013729860
·
FEI: 3013729860
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- MEDHAB, LLC
- Registration Number
- 3013729860
- FEI Number
- 3013729860
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1161 Corporate Dr W , Suite 110
- City
- Arlington
- State
- TX
- ZIP
- 76006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182495
Owner / Operator
- Firm Name
- MEDHAB LLC
- Operator Number
- 10057976
- Address
- 1161 Corporate Dr W, Suite 110
- City
- Arlington
- State
- TX
- Postal Code
- 76006
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2018-06-20 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2019-09-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-08-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2022-05-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-05-03 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2023-05-12 |
Proprietary Names
MyNotifi
StepRite
StepRIte
MHP-CUFFJUM
MyHeartPlus (cuff-oxi)
MyHeartPlus(glucometer)
MyHeartPlus (pulse-oxi)
MyHeartPlus (pulse-wellue)
MyHeartPlus (weigh scale XPRO)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device