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
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.ILO2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.ILO2026-07-31