FDA.reportPublic FDA data

BioStim INF

Primary DI
00857771003217
Brand
BioStim INF
Company
BIOMEDICAL LIFE SYSTEMS, INC.
Model
INF
Catalog number
KBSI
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
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040824000INTERFERENTIAL STIMULATOR, MODEL BMLS03-6Biomedical Life Systems, Inc.2004-04-29LIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857771003214PackageGS148In Commercial Distribution
00857771003217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085777100321410857771003214
00857771003217008577710032178577710032170857771003217

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Length7Inch
Width2Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607275600information@bmls.com

Regulatory Flags#

DUNS number
116956807
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857771003590"2"" x 2"" pigtail electrode "EERC200MEERC200M2024-08-26
20857771003594"2"" x 2"" pigtail electrode"EERC200MEERC200M2024-08-26
10857771003597"2"" x 2"" pigtail electrode - Inner Box "EERC200MEERC200M2024-08-19
00857771003897"OUT OF USE - 2"" x 2"" pigtail electrode "OUT OF USE - EERC200MEERC200M - UDI OUT OF USE2016-09-23
00857771003941"OUT OF USE - 2"" x 2"" pigtail electrode"OUT OF USE- EERC200MEERC200M - UDI OUT OF USE2016-09-23
00857771003002"2"" x 2"" pitail electrode"EERC200MEERC200M2016-09-23
00850706007304"2"" x 2"" Rectangle Electrodes"EERC200400MEERC200400M2024-08-07
00857771003422Impulse TENS D5D5KIMTD52024-08-07
00857771003125Impulse TENS D5D5KIMTD52016-09-23
00857771003996BioMed Revived IIBRVE2BRVE22019-09-20
00857771003170EMS2000EMS2000KEMS2016-09-23
00857771003187Impulse EMS D7D7KIMD72016-09-23
00857771003194GV 350GV 350KGV2016-09-23
00857771003200BioStim NMS 2NMS 2KBSNMS22016-09-23
00857771003231QuadStar IIQuadStar IIKQST2016-09-23
00857771003255QuadStar EliteQuad Star EliteKQSE2016-09-23
00857771003965BioMed RevivedRevivedBRVE2016-11-11
00857771003972BioMed FitBioMed Fit KBMFKBMF2018-03-26
00857771003347BioKnit conductive sock - universal fitGAR122GAR1222021-05-05
00850706007298BioKnit Conductive KNEEGAR130GAR1302020-04-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00858563006256MAX-IFBIOPROTECH INC.LIH2025-10-13
00860012519507CPS-2000SURGITECH, INC.LIH2025-03-31
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08032625822851GLOBUSDOMINO SRLLIH2024-10-17
08032625828037GLOBUSDOMINO SRLLIH2024-10-17
08032625829799GLOBUSDOMINO SRLLIH2024-10-17
08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
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06971763600506ROOVJOYShenzhen roundwhale technology co. LTD.LIH2024-07-31
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00817717023099VQ OrthoCareVision Quest Industries IncorporatedLIH2024-03-28
06942808291478IF-4 MultiWaveEasyMed Instruments Co., Ltd.LIH2024-01-19
00859718007289Flex-MI with ElectrodesEmsiLIH2023-09-20
00859718007272Flex-MIEmsiLIH2023-09-19
04712832961188GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
04712832961256GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04