Data / Medical devices / Canada / Airway Surgical Appliances Ltd.

Airway Surgical Appliances Ltd.: FDA-registered device maker in NEPEAN Ontario, Canada, 2 510(k) clearances

Name: Airway Surgical Appliances Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Airway Surgical Appliances Ltd. is registered with the FDA (registration 9611956) in NEPEAN Ontario, Canada. It lists 30 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 31, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9611956
FEI number: 1000213902
Address: 189 Colonnade RD., South, NEPEAN Ontario, Canada, K2E 7J4
Owner or operator: SURGICAL APPLIANCE INDUSTRIES, INC. (1511629)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: August 4, 1992
Registered through: 2026
Brand names listed: Champion, Champion CSX, OTC, PCP, Touch, Truform

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Hygiene	ILS	1	Exporter to the US	accessdata.fda.gov
Aid, Transfer	IKX	1	Exporter to the US	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Binder, Abdominal	FSD	1	Manufacturer	accessdata.fda.gov
Cane	IPS	1	Exporter to the US	accessdata.fda.gov
Components, Exercise	IOD	1	Exporter to the US	accessdata.fda.gov
Crutch	IPR	1	Exporter to the US	accessdata.fda.gov
Cushion, Hemorrhoid	LRL	U	Exporter to the US	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Repackager or relabeler	accessdata.fda.gov
Halter, Head, Traction	HSS	1	Exporter to the US	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Repackager or relabeler	accessdata.fda.gov
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain	PQY	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Abdominal	KTD	1	Manufacturer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Manufacturer	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Manufacturer	accessdata.fda.gov
Orthosis, Rib Fracture, Soft	IPX	1	Manufacturer	accessdata.fda.gov
Orthosis, Sacroiliac, Soft	IPW	1	Manufacturer	accessdata.fda.gov
Orthosis, Thoracic	IPT	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Shoe, Cast	IPG	1	Exporter to the US	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Splint, Clavicle	IQJ	1	Manufacturer	accessdata.fda.gov
Stocking, Elastic	ILG	1	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Repackager or relabeler	accessdata.fda.gov
Support, Hernia	EXN	1	Manufacturer	accessdata.fda.gov
Support, Scrotal, Therapeutic	FQJ	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 31, 2020	K192234	ActiPatch	PQY	Substantially Equivalent	Bioelectronics Corporation	accessdata.fda.gov
April 27, 2012	K121106	TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET	DWL	Substantially Equivalent	Surgical Appliance Industries, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 31, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.