FDA.reportPublic FDA data

Leckey Totstander

Primary DI
05059804100008
Brand
Leckey Totstander
Company
SUNRISE MEDICAL (US) LLC
Model
Totstander
Device description
The Totstander promotes active standing, movement and weight shifting and can be used as a stander or by therapists as an evaluation tool to assess a child’s standing ability.
Published
2023-09-24
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
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05059804100008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05059804100008050598041000085059804100008

GMDN Terms#

Term, Definition table
TermDefinition
Manual stander/exerciserA manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.

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
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408784ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408791ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408807ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00841447116479Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116486Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116493Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116509Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116516Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116523Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00193489028754GUARDIANMEDLINE INDUSTRIES, INC.INM2026-04-02
00884389150835MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150802MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150819MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408357ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408364ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408371ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408388ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408395ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408401ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408418ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408425ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408432ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408449ConvaidCONVAID PRODUCTS, INC.INM2026-02-05