Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006416350

FEI Number

3006416350

Entity Name

WUHAN PAKCARE BIO-TECHNOLOGY CO., LTD.

City/State/Country

Wuhan City Hubei, CN

Establishment Address

No.28-1 Linkong North Road, Hengdian Street, Huangpi District, Wuhan City Hubei 430301, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

WUHAN PAKCARE BIO-TECHNOLOGY CO., LTD. (Owner Number: 9101222)

Owner / Operator Contact Address

No.28-1 Linkong North Road, Hengdian Street, Huangpi District, Wuhan City, CN-HB 430301, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WUHAN PAKCARE BIO-TECHNOLOGY CO.,LTD. WUHAN PAKCARE BIO-TECHNOLOGY CO.,LTD. Moist heat pack Medcosa Lower Back Heat Wrap Hair Heat Cap by Magic Gel Medcosa Heat Glove Pack (Flaxseed) Medcosa Neck Heat Wrap Magic Gel Breast ice pack Medcosa Large Sport Ice Pack Navaris Kids ice packs, 5pcs, design 2 Navaris Hot & Cold Gel Compress XL Navaris Kids ice packs, 5pcs, wild animals Medcosa Gel Eye Mask Navaris Girls hot & cold pack for kids, set of 4 Navaris Breast cold & hot gel pads, 2pcs, blue Kwmobile Hot / Cold Gel Compress Wrap, Reusable Navaris Hot & Cold Compress Gel Packs, Round, Plush Backside ME112 Black - Ice cap, black Navaris Breast cold & hot gel pads, 2pcs, pink Magic Gel Ankle Ice Pack with gel pack Navaris Boys hot & cold pack for kids, set of 4 Magic Gel Perineal Ice Pack ME101 - Gel pack set,3 sizes, 6pcs Large Gel Ice Pack by Magic Gel HOT OR COLD Navaris Kids ice packs, 5pcs, girls Magic Gel Reusable Ice Pack (2-pack) Pink Trim Gel Pack (Ex Large) by Magic Gel Navaris Breast cold & hot gel pads, 2pcs, green Navaris Eye gel mask, cooling/warming, mintgreen ME110 - Gel pack set, 5pcs Back Pain Relief Gel Pack by Magic Gel Navaris Gel Eyepads, Clouds ME113K - Gel knee pack Navaris Animals hot & cold pack for kids, set of 4 Medcosa Ankle Compression Ice Pack Kwmobile Hot / Cold Gel Compress Belt, Black Magic Gel Ice Glove, Solid Gel Pack Version Medcosa Neck Gel Ice Pack Neck Ice Pack by Magic Gel Magic Gel Heated Eye Mask Navaris Eye gel mask, cooling/warming, pink Navaris Kids ice packs, 5pcs Medcosa Knee Compression Gel Pack Magic Gel Breast Gel Pack Magic Gel Wrist Ice Pack Wrap Medium Ice Pack by Magic Gel Navaris Hot & cold gel compress set, ankle Magic Gel Back Pain Relief Gel Pack: Hot or Cold Ice Packs for Back Injuries Leg Ice Pack by Magic Gel Medcosa Knee Gel Pack Navaris Breast cold & hot gel pads, 2pcs, grey Navaris Kids hot & cold pack, mermaid, set of 2 Medcosa Vasectomy Ice Pack Foot & Ankle Ice Pack by Magic Gel Large Back Ice Pack with Extra Compression ME112 Blue - Ice cap, blue PACK Magic Gel Shoulder Ice Pack REUSEABLE Medcosa Back Gel Pack Magic Gel Children's Ice Pack (4-pack) Navaris Eye gel mask, cooling/warming, silver, glitter Navaris Eye gel mask, cooling/warming Navaris Hot & Cold Compress Gel Packs - Set of 2 Magic Gel Knee Ice Pack All Purpose Gel Pack (x2) by Magic Gel Navaris Hot & Cold Compress Gel Packs, Round Elbow Ice Pack by Magic Gel Navaris Gel Sleepmasks MEL113S - Gel pack set, 6pcs Medcosa Gel Sock Ice Pack MEL113L - Gel pack, multi purpose Navaris Kids hot & cold pack, dinosaur, set of 2 Navaris Gel Wrist Compress ME110-2 - Gel pack set, 2pcs Medcosa Gel Ice Pack (28*38cm) Navaris Eye gel mask, cooling/warming, blue PACK HOT OR COLD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-22
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-03-25
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2016-12-01
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2020-08-24
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2007-05-04
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2007-05-04

Official Correspondent

ALAN QIN

US Agent Details

Sharon LUO Email: SHARONL@ARIELPREMIUM.COM Phone: (314) 7870737

Related Public Records

Same Entity

WUHAN PAKCARE BIO-TECHNOLOGY 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

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3017654286	GUANGDONG BINGBING HEALTH CARE PRODUCTS LTD.	Jiangmen Guangdong, CN
3011424870	XIANTAO KIMBERLY PROTECTIVE PRODUCTS CO., LTD	Xiantao Hubei, CN
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
3012436532	HEFEI ANAN TRADE DEVELOPMENT CO. LTD.	Hefei Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006416350. Last updated year: 2026. Please use registration number 3006416350 when referencing this establishment in official correspondence.