Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1832894

FEI Number

1832894

Entity Name

FKA Distributing Co., LLC

City/State/Country

Commerce Township, MI, US

Establishment Address

3000 N Pontiac Trl, Commerce Township, MI 48390, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HoMedics HoMedics HoMedics ObusForme HoMedics HoMedics 7LS HoMedics HoMedics HoMedics ObusForme HoMedics HoMedics HoMedics Bubble Bliss Elite Footbath HoMedics HoMedics ObusForme

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-27
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-03
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2004-03-08
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-12-30
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
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2020-09-14
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2020-01-16
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2020-01-16
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-09-29
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
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-11-15
PHW	Cold Pack And Vibrating Massager	Physical Medicine	Class 1	890.5975	2017-03-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-18
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-09-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-18
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2014-01-07
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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-11-15
POV	Semen Analysis Device	Hematology	Class 2	864.5220	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	2022-11-15
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	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	2022-11-15
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2006-12-14

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
3016452327	FKA Distributing Co., LLC	Riverside, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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 1832894. Last updated year: 2026. Please use registration number 1832894 when referencing this establishment in official correspondence.