FDA.reportPublic FDA data

QuadStar II

Primary DI
00857771003231
Brand
QuadStar II
Company
BIOMEDICAL LIFE SYSTEMS, INC.
Model
QuadStar II
Catalog number
KQST
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041388000COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1Biomedical Life Systems, Inc.2004-11-23GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857771003231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857771003231008577710032318577710032310857771003231

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
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
00850706007236Bio Knit Conductive cuffGAR888GAR8882020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLLIH2024-10-17