FKA Distributing Co., LLC

FDA Device Registration & Listing · Riverside, CA, US · Registration 3016452327

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
3016452327
FEI Number
3016452327
Entity Name
FKA Distributing Co., LLC
City/State/Country
Riverside, CA, US
Establishment Address
12215 Holly St., --, Riverside, CA 92509, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
FKA Brands (Owner Number: 1832894)
Owner / Operator Contact Address
3000 N Pontiac Trail, --, Commerce Twp, MI 48390, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K160145
PMA Number
N/A

All Registered Proprietary Names

HoMedics Homedics HoMedics HoMedics ObusForme HoMedics HoMedics HoMedics HoMedics HoMedics HoMedics

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 2022-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-09-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-03-27
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2023-09-29
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-09-29
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2006-12-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-15
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2004-03-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2023-09-28
PHW Cold Pack And Vibrating Massager Physical Medicine Class 1 890.5975 2017-03-30
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2022-11-15
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-15

Official Correspondent

Laura Foos

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FKA Brands
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1832894 FKA Distributing Co., LLC Commerce Township, MI, US

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016452327. Last updated year: 2026. Please use registration number 3016452327 when referencing this establishment in official correspondence.
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