FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216116283
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
A75441
Device description
Compression Stocking Aid, Large, Each
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILDAdaptor, Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILDAdaptor, DressingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216116283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216116283008402161162838402161162830840216116283

GMDN Terms#

Term, Definition table
TermDefinition
Assistive sock/pantyhose dressing deviceA device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818323022797ViveVIVE HEALTH LLCILD2026-05-11
00818323025279ViveVIVE HEALTH LLCILD2026-05-11
05050962001534EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962023048LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962057791SOXONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962080065LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110168REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110175REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146372REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146389REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156210REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156227REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156234REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156241REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156258REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156265SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962161269SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962164192EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171152HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171169HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177895HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177918HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962203983ARTHRI GRIPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962355002EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
00023601042248CarexDrive Devilbiss HealthcareILD2024-01-08
00023601042255CarexDrive Devilbiss HealthcareILD2023-09-29
30023601042256CarexCOMPASS HEALTH BRANDS CORP.ILD2023-09-29
00840252902925Cushion GripTherafin CorporationILD2023-07-06
00840252902949Cushion GripTherafin CorporationILD2023-07-06
00840252902963Cushion GripTherafin CorporationILD2023-07-06