FDA.reportPublic FDA data

IMAK Compression

Primary DI
00649833201514
Brand
IMAK Compression
Company
BROWNMED, INC.
Model
A20151
Device description
Arthritis Knee
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ISYJoint, Knee, External Limb Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISYJoint, Knee, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649833201514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649833201514006498332015146498332015140649833201514

GMDN Terms#

Term, Definition table
TermDefinition
Hip/knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the hip and knee. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
091999771
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00082161600008IMAK RSI600002020-08-26
00082161600107IMAK RSI600102020-08-26
00082161600206IMAK RSI600202020-08-26
00082161605003IMAK RSI605002020-08-26
00649833101128IMAK RSIA101122020-08-26
00649833103122IMAK RSIA103122020-08-26
00649833201309IMAK CompressionA201302020-08-26
00649833201316IMAK CompressionA201312020-08-26
00649833201323IMAK CompressionA201322020-08-26
00082161300113Polar Ice300112020-08-12
00082161300120Polar Ice300122020-08-12
00082161300137Polar Ice300132020-08-12
00082161300144Polar Ice300142020-08-12
00082161300366Polar Ice300362020-08-12
00082161301004Polar Ice301002020-08-12
00082161301011Polar Ice301012020-08-12
00082161301028Polar Ice301022020-08-12
00082161301035Polar Ice301032020-08-12
00082161301042Polar Ice301042020-08-12
00082161301059Polar Ice301052020-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186936Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00841747186943Aura PlusCOLLEGE PARK INDUSTRIES, INC.ISY2026-01-29
00195411458905IconCOLLEGE PARK INDUSTRIES, INC.ISY2025-05-28
00194711121014IntuyWillowwood Global LLCISY2025-03-21
00194711121021IntuyWillowwood Global LLCISY2025-03-21
00713980034377BIOSTEP XTAlps South, LLCISY2025-01-14
04719883460356TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
04719883460370TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2025-01-10
00195411458820IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458837IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458844IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458851IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00195411458868IconCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
00841747186707AuraCOLLEGE PARK INDUSTRIES, INC.ISY2024-06-19
04719883460004TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460028TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460035TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460059TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460066TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460073TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460103TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460110TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460158TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460264TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460271TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460288TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460301TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460318TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460325TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31
04719883460332TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.ISY2023-10-31