FDA.reportPublic FDA data

Leggero

Primary DI
10858921006239
Brand
Leggero
Company
ALTIMATE MEDICAL INC.
Model
Enzo
Catalog number
3101
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182840000Element Pediatric WheelchairLeggero, LLC2019-04-29IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B51431010PreviousHIBCC0
10858921006239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085892100623910858921006239

GMDN Terms#

Term, Definition table
TermDefinition
Attendant-only-propelled wheelchair, non-bariatricA non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.

Regulatory Flags#

DUNS number
148515216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10858921006246LeggeroReach30042026-08-18
10858921006253LeggeroTrak30022026-08-18
10858921006260LeggeroDyno30012026-08-18
10858921006222ActiveAidActiveAid BCB2026-01-05
10858921006215ActiveAidActiveAid SC2025-01-09
10858921006123ActiveAid6002022-11-18
10858921006130ActiveAid1012022-11-18
10858921006147ActiveAid2022022-11-18
10858921006154ActiveAid2852022-11-18
10858921006161ActiveAid285TR2022-11-18
10858921006178ActiveAid7202022-11-18
10858921006185ActiveAid9222022-11-18
10858921006192ActiveAid11002022-11-18
10858921006208ActiveAid12182022-11-18
10858921006000EasyStand Evolv Medium2016-09-19
10858921006017EasyStandEvolv Large2016-09-19
10858921006024EasyStandEvolv XT2016-09-19
10858921006031EasyStand Evolv Large Glider2016-09-19
10858921006048EasyStandEvolv Medium Glider2016-09-19
10858921006055EasyStandBantam Medium2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192295TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-09
04719876191953TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
04719876192318TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
00822383037127Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037134Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037141Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037158Cruiser 3 16"Drive Devilbiss HealthcareIOR2026-06-22
00822383037165Cruiser 3 18"Drive Devilbiss HealthcareIOR2026-06-22
00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
06970006394691DAYANG MEDICALGuangdong Dayang Medical Technology Co.,LtdIOR2026-06-10
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31