Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1528440

FEI Number

1000122527

Entity Name

FARETEC, INC.

City/State/Country

Painesville, OH, US

Establishment Address

1610 W. JACKSON ST. No. 6, Painesville, OH 44077, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FARETEC, INC. (Owner Number: 9004548)

Owner / Operator Contact Address

1610 W. JACKSON ST. #6, --, Painesville, OH 44077, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	1992-11-18
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2011-10-10
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2017-08-23
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-30
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2009-03-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-05-01
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2022-09-19
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2011-10-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-10-10
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-05-14
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2009-03-12
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2012-05-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2011-10-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-10-11
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2019-04-25
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	1992-11-18

Official Correspondent

TOD SACKETT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FARETEC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3016704566	DONGGUAN LUDA INDUSTRIAL CO., LTD	Dongguan Guangdong, CN
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
1000560772	BIOSCULPTOR CORPORATION	Hialeah, FL, US
8010099	MEDICON, E.G.	TUTTLINGEN Baden-Wurttemberg, DE
1062671	KENTRON HEALTH CARE, INC.	SPRINGFIELD, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528440. Last updated year: 2026. Please use registration number 1528440 when referencing this establishment in official correspondence.