FDA.reportPublic FDA data

ARMEDICA

Primary DI
B866MAM7091
Brand
ARMEDICA
Company
ARMEDICA MANUFACTURING CORP.
Model
AM709
Catalog number
AM709
Device description
LAMINATED PLATFORM MOUNT, MANUAL, STEEL, BARIATRIC 10FT PARALLEL BARS
Published
2022-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOEBars, Parallel, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOEBars, Parallel, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B866PAM7091PackageHIBCC1In Commercial Distribution
B866MAM7091PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Parallel bar exerciser, non-poweredAn exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
018941711
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B866MAMTM1001ARMEDICAAMTM100AMTM1002024-12-06
B866MAMTM12271ARMEDICAAMTM1227AMTM12272024-12-06
B866MAMTM1341ARMEDICAAMTM134AMTM1342024-12-06
B866MAMTM1401ARMEDICAAMTM140AMTM1402024-12-06
B866MAMTM1501ARMEDICAAMTM150AMTM1502024-12-06
B866MAMTM2001ARMEDICAAMTM200AMTM2002024-12-06
B866MAMTM227ARMEDICAAMTM227AMTM2272024-12-06
B866MAMTM2341ARMEDICAAMTM234AMTM2342024-12-06
B866MAMTM2401ARMEDICAAMTM240AMTM2402024-12-06
B866MAMTM2501ARMEDICAAMTM250AMTM2502024-12-06
B866MAMTM3001ARMEDICAAMTM300AMTM3002024-12-06
B866MAMTM3341ARMEDICAAMTM334AMTM3342024-12-06
B866MAMTM3401ARMEDICAAMTM340AMTM3402024-12-06
B866MAMTM3501ARMEDICAAMTM350AMTM3502024-12-06
B866MAMTM3531ARMEDICAAMTM353AMTM3532024-12-06
B866MAMTM4001ARMEDICAAMTM400AMTM4002024-12-06
B866MAMTM4501ARMEDICAAMTM450AMTM4502024-12-06
B866MAMTM5001ARMEDICAAMTM500AMTM5002024-12-06
B866MAMTM5051ARMEDICAAMTM505AMTM5052024-12-06
B866MAMTM5501ARMEDICAAMTM550AMTM5502024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854798000786Portable Parallel BarsPIVOTAL HEALTH SOLUTIONS, INC.IOE2026-03-27
00849229006154MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006161MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006178MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006185MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006192MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006208MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006215MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006222MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006239MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006246MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006253MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006260MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006277MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006284MJM THERAPY REHAB WEIGTHED BARM J M International CorporationIOE2023-07-31
00849229006291MJM THERAPY REHAB WEIGTHED BARM J M International CorporationIOE2023-07-31
00849229006307MJM THERAPY REAHB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006314MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006321MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006338MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
00849229006345MJM THERAPY REHAB WEIGHTED BARM J M International CorporationIOE2023-07-31
B866MAM7131ARMEDICAARMEDICA MANUFACTURING CORP.IOE2023-05-26
B866PAM7131ARMEDICAARMEDICA MANUFACTURING CORP.IOE2023-05-26
B866MAM7071ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7081ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7101ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7111ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAM7121ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAMTM7001ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18
B866MAMTM7021ARMEDICAARMEDICA MANUFACTURING CORP.IOE2022-11-18