KOYA MEDICAL, INC.

FDA Device Registration & Listing · Dallas, TX, US · Registration 3033981998

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033981998
FEI Number
3033981998
Entity Name
KOYA MEDICAL, INC.
City/State/Country
Dallas, TX, US
Establishment Address
2332 Valdina St, Dallas, TX 75207, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Koya Medical, Inc. (Owner Number: 10077824)
Owner / Operator Contact Address
2332 Valdina St, Dallas, TX 75207, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210885
PMA Number
N/A

All Registered Proprietary Names

Dayspring UE Dayspring LE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2020-10-02
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2021-06-21

Official Correspondent

Andy Doraiswamy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Koya Medical, Inc.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033981998. Last updated year: 2026. Please use registration number 3033981998 when referencing this establishment in official correspondence.
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