FKA Distributing Co., LLC

Commerce Township, MI, US

FKA Distributing Co., LLC appears in FDA device records in Commerce Township, MI. FDA records list 2 510(k) clearances between 2000-08-10 and 2001-10-01, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 5
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to FKA Distributing Co., LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Homedics, Inc.510(k), recall

510(k) clearance history

FDA records hold 2 510(k) clearances for FKA Distributing Co., LLC between 2000 and 2001. The busiest year on record is 2000, with 1. The most recent is 2001, with 1.

Clearances by year, as a table

510(k) clearance decisions for FKA Distributing Co., LLC, by decision year
Year	Clearances
2000	1
2001	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K012914	SONICWAVE SONIC PLAQUE REMOVER	JEQ	Substantially Equivalent	2001-10-01
K001860	PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA	IMC	Substantially Equivalent	2000-08-10

Registered establishments

FDA registered establishments for FKA Distributing Co., LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1832894	1832894	FKA Distributing Co., LLC	3000 N Pontiac Trl, Commerce Township, MI 48390 US	2026	DXN DXQ FLL ILY IME IPY IQE IRP IRT ISA and 10 more, listed in full below
3016452327	3016452327	FKA Distributing Co., LLC	12215 Holly St., Riverside, CA 92509 US	2026	DXN DXQ FLL ILY IME IRP IRT ISA LDE NGX and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-0626-2007	HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No. HP-500 (UPC 031262003652).	Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.	2007-02-09	Terminated
Z-0625-2007	HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).	Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.	2007-02-09	Terminated
Z-0624-2007	HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926).	Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.	2007-02-09	Terminated
Z-0623-2007	HoMedics Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638) and sold as Walgreens by Homedics model number 802857 (UPC 04922149892).	Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.	2007-02-09	Terminated
Z-0622-2007	HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).	Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.	2007-02-09	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain