Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008466086

FEI Number

3008466086

Entity Name

Picard Healthcare Technology (Dongguan) Co. Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No. 37, Chunfung Rd. Longbeilin, Tangxia, Dongguan Guangdong 523715, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Picard Industrial Corporation (Owner Number: 10032672)

Owner / Operator Contact Address

5F, 25, Lane 66, Juikuang Rd., Neihu Taipei, TW-TPE 114, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Obbomed Group LLC cap Face Shield, Goggle HEALTHSMART DMI DMI HEALTHSMART MM-7200 Disposable Mask MM-7310 Protective Mask DMI HEALTHSMART 3 layer Disposable Mask 3 Layer Disposable Mask (Children's Mask) KN95 Mask DMI Shoe Cover Disposable Non-Surgical Isolation Gown Disposable Medical Protective Clothing Safety Strap belt for Wheelchair OBBOMED GROUP LLC incontinence Pads Disposable Underpads incontinence Briefs Disposable Briefs incontinence Underwear DMI HEALTHSMART DMI HEALTHSMART Medical Alternating Air Pressure Mattress HEALTHSMART DMI Mattress Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-03-26
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2017-07-12
MOC	Cushion, Flotation, Therapeutic	Physical Medicine	Class 2	890.5170	2017-07-10
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-07
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2010-06-23
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2011-09-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2011-09-06
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-06
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2015-03-01
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2011-09-06
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-26
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2022-02-25
OOA	Hemorrhoid Prevention Pressure Wedge	Obstetrics/Gynecology	Class 2	884.5200	2019-08-07
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2011-09-06
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2011-09-06
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2011-09-06
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2017-09-03
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2011-09-06
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2025-03-27

Official Correspondent

Simon Liang

US Agent Details

Kevin Liu Business: Obbomed Group LLC Email: kevin@obbomed.com Phone: (626) 4008390

Related Public Records

Same Entity

Picard Industrial Corporation

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008466086. Last updated year: 2026. Please use registration number 3008466086 when referencing this establishment in official correspondence.