FDA Registration
Active
🇺🇸 United States
MERITS HEALTH PRODUCTS., INC.
Reg #: 1058069
·
FEI: 1000221992
·
Expires 2026
Products
8
Proprietary Names
16
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- MERITS HEALTH PRODUCTS., INC.
- Registration Number
- 1058069
- FEI Number
- 1000221992
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4245 EVANS AVENUE
- City
- Fort Myers
- State
- FL
- ZIP
- 33901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011687
Owner / Operator
- Firm Name
- MERITS HEALTH PRODUCTS., INC.
- Operator Number
- 9008072
- Address
- 4245 EVANS AVENUE, --
- City
- Fort Myers
- State
- FL
- Postal Code
- 33901
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2012-02-21 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2012-02-21 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2024-07-12 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2012-02-21 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2023-06-22 |
| Lift, Patient, Ac-Powered | FNG | Class 2 | General Hospital | No | 2012-02-21 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2012-02-21 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2012-02-21 |
Proprietary Names
P3101, P314, P320, P321
P312
S235
S141
P710
P301
S245
H103 Patient Lift Hydraulic
A903
S131
P101, P171, P181, P182, P183, P200, P201
Roadster Scooter
H103
S539
P325
P326A, P327
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device