BURKE L. MAYS AND ASSOCIATES, INC.

Matched from indexed company URL: BURKE, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005550372	3005550372	BURKE L. MAYS AND ASSOCIATES, INC.	1	N	2026-01-01	315 SPRINGHOUSE CIR FRANKLIN TN US 37067
1919278	1919278	BURKE, INC.	1	N	2020-04-25	1800 MERRIAM LN. KANSAS CITY KS US 66106
3004173545	3004173545	BURKE THERAPEUTICS, LLC	1	Y	2020-04-25	3633 CENTRAL AVE STE I Hot Springs AR US 71913

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
B313822501	Scout - Power Wheelchair	913-722-5658	jernst@burke-mobility.com
B314150351	Pacesaver - 3 wheeled scooter	913-722-5658	jernst@burke-mobility.com
B314150571	Pacesaver - 3 wheeled scooter	913-722-5658	jernst@burke-mobility.com

burke-mobility.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
33567	1021266511	K982158	SCOUT	ITI	1998-08-31
33567	1372054679	K965123	PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)	INI	1997-07-17
33567	1164206647	K954974	PACE SAVER LITTLE JUNIOR (MODIFICATION)	INI	1996-03-19
33567	1445292536	K925122	PACE SAVER LITTLE JR	INI	1994-03-30
33567	1592458490	K061912	FUSION	INI	2006-08-01
64606	1764031485	K050143	OMNIPRO SYSTEM	OLV	2005-02-01
33567	1293426912	K023961	SCOUT BOSS	ITI	2002-12-24
33567	1002129609
33567	1002187791
33567	1027072249
33567	1103589825
33567	1166432941
33567	1168348489
33567	1226619731
33567	1241066073
33567	1362465800
33567	1388666930
33567	1451736986
33567	1569805898
33567	1627365267
33567	1659603530
33567	1753173743
33567	1785198776
33567	1848979581
33567	1961719539
33567	2042365052
33567	2060980125

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
INI	4	2006-08-01
ITI	2	2002-12-24
OLV	1	2005-02-01

PMN#

FUSION

2006-08-01

BURKE, INC.

SCOUT BOSS

2002-12-24

BURKE, INC.

SCOUT

1998-08-31

BURKE, INC.

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

1997-07-17

BURKE, INC.

SPORTS CONTRAST THERAPY SYSTEM ST 7000

1996-04-10

BURKE NEUTECH, INC.

PACE SAVER LITTLE JUNIOR (MODIFICATION)

1996-03-19

BURKE MOBILITY PRODUCTS

EPILATOR

1995-10-19

BURKE NEUTECH, INC.

CONTRAST 7000 THERAPY SYSTEM

1995-06-07

BURKE NEUTECH, INC.

THERMAFLEX, MODEL SD 55 C.P.M.H.

1995-05-11

BURKE NEUTECH, INC.

NEURO-AIDE

1994-08-03

BURKE NEUTECH, INC.

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

1994-05-27

BURKE NEUTECH, INC.

PACE SAVER LITTLE JR

1994-03-30

BURKE MOBILITY PRODUCTS

BURKE BARIATRIC TREATMENT SYSTEM II

1993-06-04

BURKE MOBILITY PRODUCTS

LSI6000 THERMAL THERAPY SYSTEM

1993-05-26

BURKE NEUTECH, INC.

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

1991-07-19

BURKE, INC.

BOOSTER MOTORIZED THREE WHEELED VEHICLE

1990-02-22

BURKE MOBILITY PRODUCTS

COLD/HOT FLUID RADIATION PAD NEUTECH

1989-06-22

BURKE, INC.

PACESAVER & SCOUT

1984-01-30

BURKE, INC.

GUDID#

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Pacesaver - 3 wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 3-Wheeled Scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 wheeled Scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 Wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 4-Wheeled Scooter

BURKE, INC.

2016-09-01

Pacesaver - 4-Wheeled Scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 Wheeled Scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 wheeled scooter

BURKE, INC.

2016-09-01

PaceSaver - 3 Wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 4-Wheeled Scooter

BURKE, INC.

2016-09-01

Pacesave - 3 wheeled scooter

BURKE, INC.

2016-09-01

Pacesaver - 3 Wheeled Scooter

BURKE, INC.

2016-09-01

PaceSaver - Three Wheeled Electric Scooter

BURKE, INC.

2016-09-01

Burke - "Foam mattress 54"" width"

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Boss 6.75

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

PS Scout - Scout RF TPB

BURKE, INC.

2016-09-20

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Scout - Power Wheelchair

BURKE, INC.

2016-09-01

Burke - "Foam Mattress w/ bolsters - 48"""

BURKE, INC.

2016-09-01

Burke Inc - Air Mattress, Low Air Loss

BURKE, INC.

2016-09-01

Burke - Bariatric Bed

BURKE, INC.

2016-09-01