FDA.reportPublic FDA data

Utopia Gear

Primary DI
00862081000313
Brand
Utopia Gear
Company
MIDWESTERN SOLUTIONS
Model
Massage Pro Mini
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141260000ELECTRONIC PULSE STIMULATORShenzhen Jingkehui Electronic Co.., Ltd.2014-09-17NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862081000313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862081000313008620810003138620810003130862081000313

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-237-4997customerservice@utopiagear.com

Regulatory Flags#

DUNS number
048681673
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862081000368Utopia GearPro 4.02021-08-24
00862081000306Utopia GearMassage Pro 3.02016-09-27
00862081000320Utopia GearMassage Pro 2.02016-09-27
00862081000375Utopia GearPro 4.02021-08-24
00862081000337Utopia GearLarge Electrode Pads2016-09-27
00862081000344Utopia GearXL Electrode Pads2016-09-27

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