Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611956

FEI Number

1000213902

Entity Name

AIRWAY SURGICAL APPLIANCES LTD.

City/State/Country

NEPEAN Ontario, CA

Establishment Address

189 COLONNADE RD., SOUTH, NEPEAN Ontario K2E 7J4, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SURGICAL APPLIANCE INDUSTRIES, INC. (Owner Number: 1511629)

Owner / Operator Contact Address

3960 ROSSLYN DR., --, Cincinnati, OH 45209, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Champion CSX Touch Truform PCP OTC Champion OTC Champion PCP PCP OTC Champion OTC Champion OTC Champion OTC PCP PCP Champion OTC Champion OTC Champion Champion CSX OTC Truform PCP Truform Champion OTC Champion OTC PCP OTC Champion Champion CSX Truform PCP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2020-03-13
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	1992-08-04
LRL	Cushion, Hemorrhoid	Unknown	Class U	N/A	2016-06-09
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2007-08-02
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	1992-08-04
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2020-01-02
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	1992-08-04
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2007-08-02
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	1992-08-04
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2007-08-02
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2007-08-02
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	1992-08-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-02-12
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-02-04
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	1992-08-04
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2022-04-28
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	1992-08-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2007-08-02
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2007-12-19
IPS	Cane	Physical Medicine	Class 1	890.3075	1992-08-04
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2014-01-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	1992-08-04
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	1992-08-04
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2014-02-04
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	1992-08-04
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-06-05
IPR	Crutch	Physical Medicine	Class 1	890.3150	1992-08-04

Official Correspondent

Richard Stautberg

US Agent Details

James Stautberg Business: Surgical Appliance Industries, Inc. Email: jstautberg@saibrands.com Phone: (513) 2714594

Related Public Records

Same Entity

SURGICAL APPLIANCE INDUSTRIES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1523547	P.C.P. CHAMPION	RIPLEY, OH, US
1511629	SURGICAL APPLIANCE INDUSTRIES, INC.	CINCINNATI, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3014982318	HONG MING ENTERPRISE CO., LTD.	Taichung City, TW
3027500264	BREG MEXICO, S. DE R.L. DE C.V. (4)	Mexicali Baja California, MX
3005533873	SUZHOU SUNMED CO., LTD	SUZHOU CITY Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611956. Last updated year: 2026. Please use registration number 9611956 when referencing this establishment in official correspondence.