FDA.reportPublic FDA data

HTP1500

Primary DI
10615089310109
Brand
HTP1500
Company
ADROIT MEDICAL SYSTEMS, INC.
Model
HTP1500
Catalog number
HTP1500
Device description
Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K970197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970197000HTP-1500 LOCALIZED HEAT THERAPY PUMPAdroit Medical Systems, Inc.1997-09-10ILO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615089310109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061508931010910615089310109

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system control unitAn electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-458-8600scott@adroitmedical.com
8654588600kelley@adroitmedical.com

Regulatory Flags#

DUNS number
795104769
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10615089100304Soft-TempST-003ST-0032016-09-23
10615089100809Soft-TempST-008ST-0082016-09-23
10615089101004Soft-TempST-010ST-0102016-09-23
10615089101400Soft-TempST-014ST-0142016-09-23
10615089101707Soft-TempST-017ST-0172016-09-23
10615089101905Soft-TempST-019ST-0192016-09-23
10615089102407Soft-TempST-024ST-0242016-09-23
10615089103008Soft-TempST-030ST-0302016-09-23
10615089104104Soft-TempST-041ST-0412016-09-23
10615089104302Soft-TempST-043ST-0432016-09-23
10615089104401Soft-TempST-044ST-0442016-09-23
10615089105002Soft-TempST-050ST-0502016-09-23
10615089111706Soft-TempWD-017WD-0172016-09-23
10615089112000Soft-TempWD-020WD-0202016-09-23
10615089113007Soft-TempWD-030WD-0302016-09-23
10615089116008Soft-TempWD-060WD-0602016-09-23
10615089121200Soft-TempST-212ST-2122016-09-23
10615089121705Soft-TempST-217ST-2172016-09-23
10615089122009Soft-TempST-220ST-2202016-09-23
10615089122405Soft-TempST-224ST-2242016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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