Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022890

FEI Number

3926

Entity Name

VALENTINE INTL. LTD.

City/State/Country

HSICHIH CITY, TAIPEI HSIEN, TW

Establishment Address

8TH FL., NO. 149, SEC. 2,, TA TUNG RD., HSICHIH CITY, TAIPEI HSIEN 221, TW

Establishment Type(s)

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

Owner / Operator

VALENTINE INTL. LTD. (Owner Number: 8022890)

Owner / Operator Contact Address

8TH FL., NO. 149, SEC. 2,, TA TUNG RD., TAIPEI, TW-NOTA 221, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOSIS, LUMBO-SACRAL Cast Shoe Urine Bag SUPPORT GELS Patient Lift Stimulator, nerve, transcutaneous, for pain reliefStimulator, muscle, powered SLING, ARM Cervical Collar Table, mechanical Flotation Cushion Massager, therapeutic, electric Exerciser Ice Bag Nebulizer Bath, sitz, nonpowered Tongue Depressor CHAIR AND TABLE, MEDICAL HALTER, HEAD, TRACTION Commode, Toilet Support Rail, Grabber, Stool Sheath Cane Chair with Casters compressor / nebulizer Crutch SPLINT, HAND, AND COMPONENTS Electrode, cutaneous APPLICATOR, ABSORBENT TIPPED, NON-STERILE COVER, LIMB TAPE, MEASURING, RULERS AND CALIPERS MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE URINAL TIPS AND PADS, CANE, CRUTCH AND WALKER Liquid dispenser Measuring Gauge Dynamometer COMPONENTS, WHEELCHAIR Patient Transfer Aid COVER, MATTRESS ORTHOSIS, RIB FRACTURE, SOFT Pill Box Organizer LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED Overdoor Traction & Pulley Kit SPLINT, EXTREMITY, INFLATABLE, EXTERNAL Dressing Bedpan ORTHOSIS, ABDOMINAL Operating Mask BAG, DRAINAGE, WITH ADHESIVE, OSTOMY Tape and bandage, adhesive Underpad Chair Mechanical Holder for crutch, cane, wheelchair Overdoor Traction Pedal Exerciser Massager, manual Wheelchair Cushion Scale blood pressure cuff CANNULAE, BRONCHIAL UTENSIL, EATING Orthosis, cervical Stethoscope Limb Brace ATTACHMENT, COMMODE, WHEELCHAIR Magnifier Elastic Bandage Wheelchair Accessory Transfer Aid CONTAINER, LIQUID MEDICATION PERCUSSOR Surgical Mask Cast Cover Walker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2001-12-17
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2009-02-09
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2017-08-22
JZR	Support Gels	Immunology	Class 1	866.4900	2003-08-27
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1998-01-22
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-10-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2008-10-20
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2001-12-17
IQX	Hook, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2026-06-15
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2003-08-27
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2005-11-21
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	1994-09-30
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2016-08-03
KYR	Bag, Ice	General Hospital	Class 1	880.6050	1998-08-07
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-10-20
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2001-12-17
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1998-01-22
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	1998-01-22
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	1998-04-07
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2026-06-15
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-11-26
IPS	Cane	Physical Medicine	Class 1	890.3075	1998-01-22
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	1990-08-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-10-20
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-10-20
IPR	Crutch	Physical Medicine	Class 1	890.3150	1990-08-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2003-08-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-10-20
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	1998-01-22
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2008-09-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2003-08-27
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	1994-09-30
FNP	Urinal	General Hospital	Class 1	880.6730	2001-12-17
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	1990-08-02
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2003-08-27
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1998-04-07
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2003-08-27
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	1998-01-22
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	1998-04-07
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2001-12-17
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	1998-01-22
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2026-06-15
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2003-08-27
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1994-10-14
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2003-08-27
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2012-11-26
FOB	Bedpan	General Hospital	Class 1	880.6730	2000-12-08
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	1994-09-15
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-24
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2003-08-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-08-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2026-02-03
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2010-06-25
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	1992-11-02
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	1998-04-07
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	1997-10-24
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2010-06-23
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2005-11-21
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2003-08-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2008-10-20
KCE	Cannulae, Bronchial	General, Plastic Surgery	Class 1	878.4800	2003-08-27
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2003-08-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2001-12-17
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	1998-01-22
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1998-04-07
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	1992-11-02
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2012-05-31
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-11-28
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2002-04-15
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	1998-11-10
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2000-12-08
GWZ	Percussor	Neurology	Class 1	882.1700	1998-01-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-11
KIA	Cover, Cast	General Hospital	Class 1	880.6185	1997-10-24
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	1990-08-02

Official Correspondent

No official correspondent registered.

US Agent Details

Zoltan Gyorffy Business: Dyna Life Products Inc Email: INFO@VALENTINE-DYNALIFE.COM Phone: (561) 2798338

Related Public Records

Same Entity

VALENTINE INTL. LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022890. Last updated year: 2026. Please use registration number 8022890 when referencing this establishment in official correspondence.