FDA.reportPublic FDA data

BioMed Revived II

Primary DI
00857771003996
Brand
BioMed Revived II
Company
BIOMEDICAL LIFE SYSTEMS, INC.
Model
BRVE2
Catalog number
BRVE2
Device description
BioMed Revivied II
Published
2019-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180956000
K181688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180956000Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS StimulatorShenzhen Roundwhale Technology Co. , Ltd.2018-06-07NUH
K181688000R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co. , Ltd.2018-09-07IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857771003996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857771003996008577710039968577710039960857771003996

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7605790801information@bmls.com

Regulatory Flags#

DUNS number
116956807
Device count
1
Serial number
true
Manufacturing date on label
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
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
00850706007236Bio Knit Conductive cuffGAR888GAR8882020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
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06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.GZJ2026-07-14
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
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00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
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