Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1511629

FEI Number

1511629

Entity Name

SURGICAL APPLIANCE INDUSTRIES, INC.

City/State/Country

CINCINNATI, OH, US

Establishment Address

3960 ROSSLYN DR., CINCINNATI, OH 45209, US

Establishment Type(s)

Manufacture Medical 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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	1992-08-04
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2014-01-16
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1992-08-04
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2007-08-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-02-12
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	1992-08-04
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2022-04-28
PQY	Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain	Physical Medicine	Class 2	890.5290	2021-02-12
HSR	Unit, Traction, Hip, Non-Powered, Non-Penetrating	Orthopedic	Class 1	888.5890	1992-08-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2007-08-02
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2014-02-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-02-04
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	1977-12-26
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	1992-08-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1992-08-04
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2007-08-02
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	1992-08-04
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	1992-08-04
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	1992-08-04
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2014-02-04
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-06-05
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2007-12-19
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	1992-08-04
EXM	Truss, Umbilical	Gastroenterology, Urology	Class 1	876.5970	1992-08-04

Official Correspondent

Richard Stautberg

US Agent Details

No US Agent registered (Local establishment).

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
9611956	AIRWAY SURGICAL APPLIANCES LTD.	NEPEAN Ontario, CA

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1511629. Last updated year: 2026. Please use registration number 1511629 when referencing this establishment in official correspondence.