Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010148613

FEI Number

3010148613

Entity Name

DALIAN LABTEK SCIENCE & DEVELOPMENT CO LTD

City/State/Country

Dalian Liaoning, CN

Establishment Address

1-18-17, Liandong Street, Advanced Equipment Manufacturing Industry Park, Economic-Technological Development Zone, Dalian Liaoning 116021, CN

Establishment Type(s)

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

Owner / Operator

Dalian Labtek Science & Development Co Ltd (Owner Number: 10042137)

Owner / Operator Contact Address

1-18-17, Liandong Street, Advanced Equipment Manufacturing Industry Park, Economic-Technological Development Zone, Dalian, CN-LN 116085, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121718

PMA Number

N/A

All Registered Proprietary Names

A-V Hand&Foot Pump, Model LBTK-M-I 1000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2012-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Jake Sztejman Business: PRO MEDICAL SUPPLIES INC. Email: Mark.W.Gordon@outlook.com Phone: (215) 9380200

Related Public Records

Same Entity

Dalian Labtek Science & Development 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

Similar Registrations

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3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010148613. Last updated year: 2026. Please use registration number 3010148613 when referencing this establishment in official correspondence.