FDA.reportPublic FDA data

IMAK RSI

Primary DI
00082161600107
Brand
IMAK RSI
Company
BROWNMED, INC.
Model
60010
Device description
WRISTIMER®
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
IRAHand, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRAHand, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00082161600107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00082161600107000821616001070821616001070082161600107

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. 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
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
00082161301073Polar Ice301072020-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719883463494TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463500TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463517TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463524TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463531TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
00713980001331LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001348LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001355LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001362LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001379LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001386LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001393LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001409LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001416LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001423LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001430LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980001447LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980004332LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980004615LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005131LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005148LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005179LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980005384LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006008LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006015LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980006046LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008620LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008637LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008644LOCK DEVICESAlps South, LLCIRA2024-12-30
00713980008651LOCK DEVICESAlps South, LLCIRA2024-12-30