Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006792041

FEI Number

3006792041

Entity Name

Shenzhen Pango Medical Electronics Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen Guangdong 518115, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Pango Medical Electronics Co., Ltd (Owner Number: 10037877)

Owner / Operator Contact Address

No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electronic Blood Pressure Monitor PG-800B9 Brand Name: coosh CBPM001 = PG-800B6-2 CBPM002 = PG-800B9 PG-800B11=TM-BP2000 PG-800B5-1=ZZABP01 22-52cm cuff 22-42cm cuff PG-800B10 = TM-BP3000 PG-800B36 PG-800B12 Metene PG-800B9 Metene PG-800B8 LPOW PG-800B ANKOVO PG-800B15 FANRY PG-800B5-1 FLEXMED RBD002 = PG-800B5-1 Vitallys Plus VBPM-3A2 = PG-800BD caring mill PG-800B10 PG-800B10=SENBPUPARM Electronic Blood Pressure Monitor PG-800B18, PG-800B19, PG-800B19L, PG-800B28, PG-800B29, PG-800B51 Wrist Blood Pressure monitor=PG-800A19 PG-800A-1 PG-800AD-1 PG-800A9 Electronic Blood Pressure Monitor 22-52cm cuff 22-42cm cuff Brand Name: AccuMed ABP802 = PG-800B11 ABP801 = PG-800A11 PG-800A25 PG-800A11=TM-BP1000 PG-800A36 HA-XYJ-003 = PG-800A12 GM-500W = PG-800A36 GM-800A = PG-800B36 LAKMUS PRO PG-800A11 PARAMED blood pressure monitor PG-800A12 caring mill PG-800A7 life2O PGHB-1 = PG-800A11 ELITRONIX or OEM AD-537 = PG-800A7 ELITRONIX or OEM AD-577 = PG-800AD PG-800A7=SENBPWRIST Neck Massager Neck P3(reference to Neck K7,Brand name:Buckeye) PG-2404G intelligent eye massage Scalp Massager(PG-2701,PG-2704) PG-2015F1 Portable Air Compression Leg Massager BRM-5800 Silicon Facial Cleaner PG-2015F3 = M1700 PG-2404G15 eye massage PG-M180 = M1300 Body Sport BDSM300 = PG-2404G5 Body Sport BDSM400 = PG-2701 Intelligent Knee Massager PG-2015F3 PG-2404G5 = EM-R0108LA PG-2404G15 = M1000 PG-2404G5 Eye Massager PG-2404G5=SLEYMSG40 PG-2404G5=SLEYMSG40PK Neck kneading massager Neck K1 Intelligent Heating Belt (PG-2507,PG-2511) Face Massager(BRM-5700,LL-PHOTO) Waist Massager ECA-ERGO-MAS101(reference to KTR-305,Brand name:Ergo CoreActive) Knee Massager Knee R2(reference to Knee 5,Brand name:Buckeye) SLNKMSG131(reference to P6K) Neck Massager (PG-2601B15,PG-2601B27,P6K) EYE 5 ,EYE 6, EYE 7 ,EYE 8,EYE 9,EYE 8 YOUNG,OKO Intelligent Heating Belt PG-2510 Neck Kneading Massager Neck K6 Neck Kneading Massager Neck K7 Eye Massager Eye M1(reference to Eye 7,Brand name:Buckeye) Arm Blood Pressure Monitor PG-800B27 Arm Blood Pressure Monitor PG-800B32 Arm Blood Pressure Monitor PG-800B26 Arm Blood Pressure Monitor PG-800B36 Arm Blood Pressure Monitor PG-800B37 Arm Blood Pressure Monitor PG-800B31 Arm Blood Pressure Monitor PG-800B35 Arm Blood Pressure Monitor PG-800B42 Arm Blood Pressure Monitor PG-800B22 Arm Blood Pressure Monitor PG-800B33 Arm Blood Pressure Monitor PG-800B23 Procare PG-800B31 Arm Blood Pressure Monitor PG-800B43 CKeep PG-800B23 Procare PG-80027 KX Medical BP013US =PG-800B32 Electronic Blood Pressure Monitor A27=PG-800B27 JNK-BP396 = PG-800B27 Digital Hearing Aid-PG-Z108-2 Digital Hearing Aid-PG-Z104BT-2 Hearing Aid-PG-Z601 Digital Hearing Aid-PG-Z106BT-1 Digital Hearing Aid-PG-Z108BT-2 Digital Hearing Aid-PG-Z104-2 Digital Hearing Aid-PG-Z104BT-1 Digital Hearing Aid-PG-Z106-2 Digital Hearing Aid-PG-Z104D-2 Digital Hearing Aid-PG-Z108BT-1 Digital Hearing Aid-PG-Z108-1 Digital Hearing Aid-PG-Z202 Digital Hearing Aid-PG-Z106BT-2 Digital Hearing Aid-PG-Z106-1 Digital Hearing Aid-PG-Z203 Digital Hearing Aid-PG-Z201 Digital Hearing Aid-PG-Z104D-1 Digital Hearing Aid-PG-Z104-1 Hearing Aid-PG-Z501 22-42cm cuff 22-52cm cuff Electronic Blood Pressure Monitor, PG-800B Infrared thermometer PG-IRT1603 LAKMUS PRO PG-IRT1602 Infrared thermometer PG-IRT1601 Electronic Thermometer AT11=PG-IRT1603 Infrared thermometer PG-IRT1602 LAKMUS PRO PG-IRT1603 caring mill PG-IRT1603 Procare PG-IRT1602 Dr.ProtekT PG-IRT1603 = PG-IRT1603 PARAMED ear & forehead thermometer PG-IRT1603 SeemtraMed PG-IRT1603 JNK-TM-399 = PG-IRT1603 First 5 California PG-IRT1602 = PG-IRT1602 Mueller Medical Austria IT-800 = PG-IRT1603 bt-degree IR PG-IRT1602 BOOMCARE PG-IRT1603 = PG-IRT1603 life2O PGCH-1 = PG-IRT1602 infrared ear/forehead thermometer EDM08-MPBD = PG-IRT1603 Mueller Medical Austria IT-700 = PG-IRT1602 Santastic PG-IRT1602 = PG-IRT1602 ByFlo Products Inc. PG-IRT1602 Infrared Thermometer-TI001US=PG-IRT1602 Intelligent Waist and Abdomen Massager(Waist M5)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-09-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-12-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-08-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2012-05-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-12-04
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2022-02-16
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-11-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-08-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-05-29
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-11-30

Official Correspondent

Huijun Li

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shenzhen Pango Medical Electronics 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006792041. Last updated year: 2026. Please use registration number 3006792041 when referencing this establishment in official correspondence.