Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033519

FEI Number

3003139448

Entity Name

OPPO MEDICAL, INC.

City/State/Country

Seattle, WA, US

Establishment Address

Seattle City Center, 1420 5th Ave Ste 220080, Seattle, WA 98101, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OPPO MEDICAL, INC. (Owner Number: 9042440)

Owner / Operator Contact Address

Seattle City Center, 1420 Fifth Ave, Ste 220080, Seattle, WA 98101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oppo Oppo Oppo Sliding-Fit wrist splint Oppo Oppo, Accutex Oppo Accutex Knee Guardian Oppo Oppo Oppo, Accutex, Ankle Guard OPPO LP Oppo Oppo Oppo Oppo Oppo OPPO LP Oppo, Accutex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2012-03-16
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2012-03-15
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2012-03-16
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2011-11-21
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2012-03-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-11-21
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2010-02-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-03-16
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2012-03-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2012-03-14
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-11-19
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2012-03-16
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2012-03-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2012-03-15
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2011-11-21
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2012-03-16
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-11-19
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2010-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OPPO MEDICAL, INC.

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

View Entity Profile →

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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2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3008261717	XIAMEN COMPOWER MEDICAL TECH. CO., LTD.	Xiamen Fujian, CN
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033519. Last updated year: 2026. Please use registration number 3033519 when referencing this establishment in official correspondence.