Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011149139

FEI Number

3011149139

Entity Name

Dongguan Esino Manufacturing Service Co., Ltd

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.5 Xifu Street, Lincun, Tangxia Town, Dongguan Guangdong 523711, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan Esino Manufacturing Service Co., Ltd. (Owner Number: 10052299)

Owner / Operator Contact Address

No. 5 Xifu Street, Lincun, Tanxia Town, Dongguan, CN-GD 523711, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hypersphere 2 Hypervolt BT Hypervolt Go Hypersphere Go Hypervolt Go 2 Vyper Go Vyper 2 Hypervolt 2 Pro Hypervolt 2 Hypervolt Plus BT Hypersphere Hypershere Mini Vyper 3 Hyperice ICE Compression Device ICE CELL MyoBelt Hand Massager PhysioFlex MyoSphere MyoLite PhysioGo PhysioPedal Capiflo 5001 DVT Sequential Compression Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2016-08-02
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2019-10-15
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2018-08-29
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-04-14

Official Correspondent

Winnie Lee

US Agent Details

Cherry Qiu Email: Cherry@nobol.com Phone: (949) 3333657

Related Public Records

Same Entity

Dongguan Esino Manufacturing Service 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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011149139. Last updated year: 2026. Please use registration number 3011149139 when referencing this establishment in official correspondence.