FDA Registration
Active
🇺🇸 United States
Navajo Manufacturing Company Inc.
Reg #: 1720839
·
FEI: 1000065475
·
Expires 2026
Products
12
Proprietary Names
16
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- Navajo Manufacturing Company Inc.
- Registration Number
- 1720839
- FEI Number
- 1000065475
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5330 FOX ST.
- City
- Denver
- State
- CO
- ZIP
- 80216
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221798
Owner / Operator
- Firm Name
- Navajo Manufacturing Company Inc.
- Operator Number
- 1720839
- Address
- 5330 Fox Street, --
- City
- Denver
- State
- CO
- Postal Code
- 80216
- Country
- US
- Correspondent
- Felix A Morales
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2007-06-28 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2024-09-18 |
| Floss, Dental | JES | Class 1 | Dental | No | 2007-07-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-09-04 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2013-01-28 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2018-02-05 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-01-28 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2024-04-04 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2023-06-27 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2024-09-12 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2007-07-27 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2026-04-03 |
Proprietary Names
Handy Solutions Toothbrush
Good to Go Toothbrush
Denture Brush
Safety Glasses
Handy Solutions
Handy Solutions Pulse Oximeter
Magnifying Spectacle
Liv+BeWell
Ice Bag
Liv+BeWell Wrist Brace
Handy Solutions Arthritis Glove
Handy Solutions Wrist Brace
LIve+BeWell Arthritis Glove
Humidifier
Sunglasses
HANDY SOLUTIONS EARLY RESULT ONE STEP PREGNANCY TEST KIT
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device