Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016159364

FEI Number

3016159364

Entity Name

Shanghai Honca Import and Export co.,Ltd

City/State/Country

Shanghai, CN

Establishment Address

Rm 6364 Building 1 No.1-9 Lane 99, Shenmei rd Pudong Area, Shanghai 201414, CN

Establishment Type(s)

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

Owner / Operator

Shanghai Honca Import and Export co.,Ltd (Owner Number: 10061793)

Owner / Operator Contact Address

Rm 6364 Building 1 No.1-9 Lane 99 Shenmei rd Pudong Area, Shanghai, CN-NOTA 201414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Cold Therapy System, Cold therapy pad, cold therapy set, Ice Bucket, water bag Arm Sling Massage chair, household massage chair Sound Body 360 Hot Cold Brace For Knee, Bandage Elbow Support, Bandage Wrist Support Bandage Knee Support, Bandage Ankle Support, Bandage Back Support, Bandage Palm Support Heat pack, hot pack, heating pad, moist heat pack. Elastic Bandage, Elastic strap Wound Dressing, Transparent Dressing, Shower shield bandage protector, waterproof cast protector, Disposable Waterproof Cast Protector, cast cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2019-11-20
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-09-10
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-11-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-11-19
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2019-11-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-11-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-11-10
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2019-11-20

Official Correspondent

Will Yue

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Honca Import and Export co.,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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3011684767	NICE RECOVERY SYSTEMS LLC	Boulder, CO, US
3016171827	SHENZHEN SHUICHANG TECHNOLOGY CO., LTD	Shenzhen City Guangdong, CN
3015004731	ADVANCED AMBULATORY, INC	Houston, TX, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3010675856	KINETEC USA	Jackson, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016159364. Last updated year: 2026. Please use registration number 3016159364 when referencing this establishment in official correspondence.