FDA.reportPublic FDA data

HealthmateForever

Primary DI
00817856020614
Brand
HealthmateForever
Company
HEALTHMATE INTERNATIONAL,LLC
Model
Vibrating Heating Shoes
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817856020611PackageGS110In Commercial Distribution
00817856020614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081785602061110817856020611
00817856020614008178560206148178560206140817856020614

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
014593382
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817856020003HealthmateForeverYK15AB White2016-09-16
00817856020027HealthmateForeverPro12ab Black2016-09-18
00817856020034HealthmateForeverPro12ab Silver2016-09-18
00817856020058HealthmateForeverNK10GL Black2016-09-18
00817856020065HealthmateForeverNK10AB Black2016-09-18
00817856020072HealthmateForeverNK10AB Silver2016-09-18
00817856020089HealthmateForeverHM8ML Black2016-10-11
00817856020096HealthmateForeverBM8ML Black2016-10-11
00817856020119HealthmateForeverHM8GL Black2018-04-25
00817856020140HealthmateForeverPro6abs Black2016-10-11
00817856020225HealthmateForeverHM8GL Silver2017-01-13
00817856020232HealthmateForeverHM8GAB Silver2017-01-13
00817856020249HealthmateForeverHM8GAB Black2017-01-13
00817856020256HealthmateForeverHM8ML Silver2017-01-13
00817856020263HealthmateForeverHM8ML Blue2017-01-13
00817856020270HealthmateForeverPro15ab Black2017-01-13
00817856020287HealthmateForeverPro15ab Silver2017-01-13
00817856020294HealthmateForeverPro18ab Silver2017-01-13
00817856020300HealthmateForeverPro18ab Black2017-01-13
00817856020317HealthmateForeverHM15GAB Black2017-01-13

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