FDA.reportPublic FDA data

APT PERFORMER

Primary DI
00092237624784
Brand
APT PERFORMER
Company
Drive Devilbiss Healthcare
Model
5100D006
Device description
APT UPPER MOTOR REPAIR PART
Published
2024-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092237624784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092237624784000922376247840922376247840092237624784

GMDN Terms#

Term, Definition table
TermDefinition
Bicycle exerciserAn exercise apparatus designed to provide the same physical activity of pedalling a bicycle while remaining stationary, primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period; it may also promote lower-body, stomach, arm, and back muscle strength. The device typically consists of a bicycle-like frame mounted on struts, pedals geared via a chain or belt to a variable resistance, handlebars, with a fixed seat or attachment for a wheelchair. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
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

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Primary DI, Brand, Company table
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04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
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