FDA.reportPublic FDA data

ThermoTek WRAP, SHLD HALF ARM W/HRN, SPU, UF

Primary DI
00850033615326
Brand
ThermoTek WRAP, SHLD HALF ARM W/HRN, SPU, UF
Company
THERMOTEK, INC.
Model
0P9BSSWHMR3-U
Catalog number
0P9BSSWHMR3-U
Device description
WRAP, SHLD HALF ARM W/HRN, SPU, UF
Published
2026-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061866000NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPSThermotek, Inc.2006-08-22JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033615326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033615326008500336153268500336153260850033615326

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, single-useA device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
847899911
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033615227Echo Ultrasound Device (PRC) 0V52XX1001JK01-CTN0V52XX1001JK01-CTN2026-02-23
00850033615258Echo Ultrasound Device (PRC)0V52XX1001JK010V52XX1001JK012026-02-23
00850033615289Echo Ultrasound Device (USA)0V52XX1002JK01-CTN0V52XX1002JK01-CTN2026-02-23
00850033615340Echo Ultrasound Device (USA)0V52XX1002JK010V52XX1002JK012026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRC0V52XX1003JK01 0V52XX1003JK01 2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES0V52XX1003JK01-CTN0V52XX1003JK01-CTN2026-02-23
00850033615425Echo Ultra Sound Gel Pods, Carton0V52XX1004JK01-CTN0V52XX1004JK01-CTN2026-02-23
00850033615487Echo Ultra Sound Gel Pod, Single0V52XX1004JK010V52XX1004JK012026-02-23
00850033615500Echo APPLICATOR, SINGLE, USND0V52XX1005JK010V52XX1005JK012026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USND0V52XX1006JK010V52XX1006JK012026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USND0V52XX1007JK010V52XX1007JK012026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USND0V52XX1008JK010V52XX1008JK012026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USND0V52XX1009JK010V52XX1009JK012026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USND0V52XX1010JK010V52XX1010JK012026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USND0V52XX1011JK010V52XX1011JK012026-02-23
00850033615616ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF0P9BCFKNMR3EXT-U 0P9BCFKNMR3EXT-U 2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES0V52XX1012JK01-CTN 0V52XX1012JK01-CTN 2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USA0V52XX1012JK010V52XX1012JK012026-02-23
00850033615647THERAPY SYSTEM, ARTEK PRO-020P9PTATP020P9PTATP022026-02-23
00850033615081ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZE0P9BLSBXBK0P9BLSBXBK2026-02-21

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