Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007218972

FEI Number

3007218972

Entity Name

JASAN INTERNATIONAL LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

Blk L, 3/F., International Ind. Centre,, 2-8 kwei Tei St, Fo Tan, Shatin,, Hong Kong 852, HK

Establishment Type(s)

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

Owner / Operator

Jasan International Limited (Owner Number: 10031958)

Owner / Operator Contact Address

Blk L, 3/F., International Ind. Centre,, 2-8 kwei Tei St, Fo Tan, Shatin,, Hong Kong, HK-NOTA 852, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Support neoprene tennis elbow brace; Waist belt support/Lumbar support; Bed Pan/Urinal/PP-Tray Exercise-Pulley, traction Cushion Seat, Mattress, Frame, Tray Walker Ankle brace; Jasan Jasan Leg lifter,pedal exerciser Elbow and wrist brace support; Knee Braces sleeve support; Bath-Bench, Bath-Seat, Bathtub-Safety-Bar, Grab-Bar, Toilet-Safety-Frame Folding Dual Purpose Escort Chair Jasan Jasan Exercise-Peddler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2018-12-09
FOB	Bedpan	General Hospital	Class 1	880.6730	2020-12-29
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2021-12-15
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2021-12-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2010-11-10
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-12-09
NXE	Walker, Mechanical, Poly Vinyl Chloride (Pvc)	Physical Medicine	Class 1	890.3825	2010-11-10
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2010-03-25
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2020-12-29
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-12-09
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2018-12-09
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2021-12-15
IPS	Cane	Physical Medicine	Class 1	890.3075	2010-03-26
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2010-11-10
IOE	Bars, Parallel, Exercise	Physical Medicine	Class 1	890.5370	2021-12-15

Official Correspondent

Grace Choi

US Agent Details

James St. WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Jasan International Limited

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007218972. Last updated year: 2026. Please use registration number 3007218972 when referencing this establishment in official correspondence.