FDA.reportPublic FDA data

Inspired by Drive

Primary DI
00822383987651
Brand
Inspired by Drive
Company
Drive Devilbiss Healthcare
Model
WCM-A2800-FR
Device description
Inspired Stroller Bases Product Description Miko Canopy, Size 2, Fire Truck Red
Published
2020-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
LBESTROLLER, ADAPTIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBEStroller, AdaptivePhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130644000PEDIATRIC FOLDING WHEELCHAIRColumbia Medical Mfg, LLC2013-10-16LBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383987651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383987651008223839876518223839876510822383987651

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, occupant-driven, rear-wheels-operated, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device. The occupant moves the device by rotating both rear wheels. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840117408029ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408036ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408043ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408050ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408067ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408074ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408081ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408098ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408104ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408111ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408128ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408135ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408142ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408159ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408166ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
00840117408173ConvaidCONVAID PRODUCTS, INC.LBE2026-02-05
10840117400013ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400037ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400044ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400075ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400082ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400099ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400129ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400341ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400358ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400365ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117400761ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16
10840117401027ConvaidCONVAID PRODUCTS, INC.LBE2023-01-16