FDA Registration
Active
🇺🇸 United States
FARETEC, INC.
Reg #: 1528440
·
FEI: 1000122527
·
Expires 2026
Products
22
Proprietary Names
28
Establishment Types
4
Classifications
22
Registration Details
- Registration Name
- FARETEC, INC.
- Registration Number
- 1528440
- FEI Number
- 1000122527
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1610 W. JACKSON ST. No. 6
- City
- Painesville
- State
- OH
- ZIP
- 44077
- Country
- US
Regulatory Submissions
- 510(k) Number
- K781491
Owner / Operator
- Firm Name
- FARETEC, INC.
- Operator Number
- 9004548
- Address
- 1610 W. JACKSON ST. #6, --
- City
- Painesville
- State
- OH
- Postal Code
- 44077
- Country
- US
- Correspondent
- TOD - SACKETT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 1992-11-18 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2011-10-10 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2017-08-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-30 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2009-03-12 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2014-05-01 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2022-09-19 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2011-10-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2011-10-10 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2019-05-14 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2009-03-12 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2012-05-07 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2011-10-10 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-10-11 |
| Cricothyrotomy Kit | OGP | Class 2 | Anesthesiology | No | 2019-04-25 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1992-11-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-12-14 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2011-02-28 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2010-07-12 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2014-04-02 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2019-05-17 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2019-05-17 |
Proprietary Names
QD Splints
CT-6 Traction Splint
Tlll Traction Splints
NP Tube
EL3000/EL2000 Litter Carrier
FareTec PST
Face Shield
Litter, Basket Stretcher, Spine Board, Back Board, Scoop Stretcher, Head Block
Chest Seal, Bolin Chest Seal, Occlusive Dressing
RESPONDER PELVIC BINDER
IFAK
Combat Tape
Shears,black handle
FS-3
Redi Splint
Redi Universal Splint
FareTec Inc. EL4000 Litter
Windless Tourniquet
Compression Gauze
Cric Kit
FareTec Finger Splint
Responder Transfer Sheet
FareTec Wheeled Litter Carrier
Compression Bandage
FS8030V Elastic Bandage
Ear Defender
Airway Tube
Mask
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only