FDA.reportPublic FDA data

Brace Direct

Primary DI
00689481624044
Brand
Brace Direct
Company
BRACE ALIGN LLC
Model
CTY243
Device description
Experience the next level of pain relief with the Brace Direct BlueIce Cold Cryotherapy Machine. Perfect for arthritis, post-surgical recovery, and injury treatment, this machine combines portability and efficiency for targeted cold therapy.
Published
2025-03-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00689481624044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689481624044006894816240446894816240440689481624044

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy systemAn assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108094498
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613527834173Brace DirectCTY4082025-03-19
00686162751389Brace DirectCTY159-22025-03-19
00686162753284Brace DirectCTY194-Unit-Plus-Uni-Pad2025-03-19
00860011821847Brace DirectUCTY194-22025-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.ILO2023-04-05
08809802643260CTC-7DAESUNG MAREF CO.,LTD.ILO2022-05-09
00810041988126ViveVIVE HEALTH LLCILO2021-11-30