Data / Medical devices / United States / Surgical Appliance Industries, Inc.

Surgical Appliance Industries, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 2 510(k) clearances

Name: Surgical Appliance Industries, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Surgical Appliance Industries, Inc. is registered with the FDA (registration 1511629) in Cincinnati, OH, United States. It lists 30 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 31, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1511629
Address: 3960 Rosslyn DR., Cincinnati, OH, United States, 45209
Owner or operator: SURGICAL APPLIANCE INDUSTRIES, INC. (1511629)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: December 26, 1977
Registered through: 2027
Brand names listed: Champion, Champion CSX, OTC, PCP, Touch, Truform

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Traction	ILZ	1	Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Manufacturer	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Binder, Abdominal	FSD	1	Manufacturer	accessdata.fda.gov
Cage, Knee	ITM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cover, Cast	KIA	1	Repackager or relabeler	accessdata.fda.gov
Halter, Head, Traction	HSS	1	Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Complaint file establishment, 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	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Repackager or relabeler	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
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Splint, Clavicle	IQJ	1	Manufacturer	accessdata.fda.gov
Stocking, Elastic	ILG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Contract manufacturer, Manufacturer, 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
Truss, Umbilical	EXM	1	Manufacturer	accessdata.fda.gov
Unit, Traction, Hip, Non-Powered, Non-Penetrating	HSR	1	Manufacturer	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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 7, 2011	60371	Not yet classified	Terminated	Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve ti	During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted	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.