FDA.reportPublic FDA data

Leckey PAL

Primary DI
05059804135000
Brand
Leckey PAL
Company
SUNRISE MEDICAL (US) LLC
Model
PAL
Device description
The PAL Seating System gives improved stability which helps reduce fatigue and allows the child longer periods of concentration and fine motor activity.
Published
2023-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05059804135000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05059804135000050598041350005059804135000

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose stool/chairA seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962525056
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016958061888JAY LITEPRO CUSHIONJLPXXYY2026-03-05
00016958057591RGKOctane2023-09-05
00016958059373RGK Octane Sub4Sub 42023-09-05
00016958060249RGK Octane FXFX2023-09-05
00016958053593Quickie QX/QXiQX/QXiEIF62021-05-04
00016958053661Quickie SR45SR45EIZ92021-05-04
00016958056761Quickie XtenderQuickie XtenderEIXT2021-05-03
00016958058413Cool Cube / TouchDrive 2CCB / TD2SWI2021-05-12
00016958058437CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStickSwitch-ItSWI2021-05-12
00016958050110Jay EasyEasyE2607 / E26082023-09-12
00016958050127Jay Basic BackBasic Back2023-09-12
00016958050134Jay Focus Point BackFocus Point Back2023-09-12
00016958053135Jay Encompass BackEncompass2023-09-12
00016958053647Zippie VoyageVoyage; Voyage VIPEIZ14. EIZ16, EIZ182023-09-12
00016958056563Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoE2622/ E2623 / E2624 / E26252023-09-12
00016958058451Switch-It MicroGuide, MicroPilot, VersaGuide, VersaGuideEZ, SWI2023-09-12
00016958059694 Xtreme X8 4WDXtreme X8EIMM2023-09-12
00016958059380EmpluseF35EISP112025-04-21
00016958059526QuickieQS5 XEIF72024-12-02
00016958059366EmpluseR20EISP92024-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00023601023186CarexDrive Devilbiss HealthcareILS2026-04-29
14895262521362HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
14895262521829SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521048HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521390HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521574HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521727SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521304HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521670HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521779SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521578HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521677HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521721SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521776SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521544HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521551HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521159HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521166HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
00194346699421EquateWAL-MART STORES, INC.ILS2026-04-17
04895262521013HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521020HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521037HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521051HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521068HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521044HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-13
00023601023827CarexDrive Devilbiss HealthcareILS2026-04-07
00023601658500CarexDrive Devilbiss HealthcareILS2026-01-12
00023601088215CarexDrive Devilbiss HealthcareILS2025-10-16
00023601088208CarexDrive Devilbiss HealthcareILS2025-06-25
00810178882403ViveVIVE HEALTH LLCILS2025-05-20