FDA.reportPublic FDA data

IMAK RSI

Primary DI
00649833301375
Brand
IMAK RSI
Company
BROWNMED, INC.
Model
A30137
Device description
Knee Strap
Published
2020-08-27
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
00649833301375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649833301375006498333013756498333013750649833301375

GMDN Terms#

Term, Definition table
TermDefinition
Knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the 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
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327181MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327198MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327204MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327211MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327228MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327235MEDIMEDI MANUFACTURING, INC.IQI2026-07-20