FDA.reportPublic FDA data

ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF

Primary DI
00850033615616
Brand
ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF
Company
THERMOTEK, INC.
Model
0P9BCFKNMR3EXT-U
Catalog number
0P9BCFKNMR3EXT-U
Device description
ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF
Published
2026-02-23
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
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

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
00850033615616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033615616008500336156168500336156160850033615616

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
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
00850033615104"ThermoTek WRAP, KNEE,ROM BRACE, 2XL, 13"""0P9BRMLX13-2XL0P9BRMLX13-2XL2026-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21