Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014663650

FEI Number

3014663650

Entity Name

PLUS MEDITECH CO., LTD. PLANT 2

City/State/Country

Tainan City, TW

Establishment Address

43, Jhonghua W Rd., Sec 1, S. District, Tainan City 70266, TW

Establishment Type(s)

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

Owner / Operator

Plus Meditech Co., Ltd. Plant 2 (Owner Number: 10058037)

Owner / Operator Contact Address

43, Jhonghua W Rd., Sec 1, S. District, Tainan City, TW-TNN 70266, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LP Oppo Oppo Oppo LP LP Oppo Oppo LP Xtremus Oppo Knee Guardian LP Knee Immobilizer Accutex LP OPPO Oppo Accutex LP Oppo LP Air Lite Ankle Guard Accutex LP Air Gel Ankle Brace Oppo Accutex Xtremus LP Oppo LP Accutex Oppo LP LP Accutex Oppo LP Oppo Oppo Sliding-Fit wrist splint Oppo Pelvic Support LP Pelvic Support Oppo Oppo Voyage Series Oppo Eminence Series Oppo Caring Series LP OPPO Maxtaping A+ Oppo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-06-29
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2018-06-29
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2018-06-29
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-06-29
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-06-28
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-06-29
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-11-19
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2018-06-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-06-29
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2018-06-29
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2018-06-29
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2018-06-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-06-29
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2018-06-28
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2018-06-29
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2018-06-29
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2018-06-29
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-11-19
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2018-06-28
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2018-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

Theresa Wong Email: twong@lp-support-usa.com Phone: (206) 5758843

Related Public Records

Same Entity

Plus Meditech Co., Ltd. Plant 2

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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3013002868	BRACE ALIGN	Soddy Daisy, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014663650. Last updated year: 2026. Please use registration number 3014663650 when referencing this establishment in official correspondence.