FDA.reportPublic FDA data

Pulse Massager

Primary DI
00817746020397
Brand
Pulse Massager
Company
BETTER BASICS, INC.
Model
MP-TENS310-US
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K131921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131921000ELECTRONIC PULSE STIMULATORShenzhen Jingkehui Electronic Co.., Ltd.2013-11-15NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817746020403PackageGS11In Commercial Distribution
00817746020410PackageGS140In Commercial Distribution
00817746020397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817746020403008177460204038177460204030817746020403
00817746020410008177460204108177460204100817746020410
00817746020397008177460203978177460203970817746020397

GMDN Terms#

Term, Definition table
TermDefinition
Pain-relief static magnetA magnetized metal device designed to be worn on any part of the body (non-dedicated) and intended to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief of body aches and pains (e.g., from arthritis, sciatica, whiplash, spinal injuries, sports injuries, and muscle soreness/stiffness). It is typically encased in a synthetic material (plastic) or covered with gold (Au) to minimize skin allergies, and may be attached to clothing or applied directly to the skin with an adhesive plaster at the site of the pain. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013029698
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817746020366Pulse MassagerMP-TENS-1102016-11-18
00817746020915Pulse MassagerMP-TENS510-US2017-05-26
00817746021226Pulse OximeterMP-OX3002017-09-15
00817746020151Pulse oximeterMP-OX150-US2016-11-18
00817746020182Pulse oximeterMP-OX200-US2016-11-18
00817746020212Pulse oximeterMP-OX250-US2016-11-18
00817746026665Fever ThermometerMP-IRT4502017-09-15
00817746020243Fever therometerMP-TM21-US2016-11-18
00817746020274Fever therometerMP-IRT350-US2016-11-18
00817746020007blood pressure monitorMP-BPM20A-US2016-11-18
00817746020038blood pressure monitorMP-BPM50W-US2016-11-18
00817746020069blood pressure monitorMP-BPMW60-US2016-11-18
00817746020090blood pressure monitorMP-BPMA70-US2016-11-18
00817746020120blood pressure monitor MP-BPM80A-US2016-11-18
00817746020304Body fat scaleSW-SBS5002016-11-18
00817746021233Pulse OximeterMP-OX3002017-09-15
00817746021325Fever ThermometerMP-IRT4502017-09-15
00817746020335Body fat scaleSW-SBS7002017-01-17
00817746020342Body fat scaleSW-SBS7002017-01-17

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