FDA.reportPublic FDA data

IMAK Compression

Primary DI
00082161510550
Brand
IMAK Compression
Company
BROWNMED, INC.
Model
51055
Device description
SHIN SLEEVE™
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00082161510550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161510550000821615105500821615105500082161510550

GMDN Terms#

Term, Definition table
TermDefinition
Ankle joint orthosisAn externally applied orthopaedic device used as a component of a lower limb orthosis to allow or control motion of the ankle joint. 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
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221358MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221365MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221372MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221389MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221396MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221402MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221419MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221426MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221433MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221440MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221457MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221464MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221471MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221488MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221495MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221501MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221563MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221570MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221587MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221594MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221600MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221617MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221624MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20