FDA.reportPublic FDA data

Slendertone Abs 5

Primary DI
15099058517020
Brand
Slendertone Abs 5
Company
BIO-MEDICAL RESEARCH LIMITED
Model
517 - US
Catalog number
0517-5010
Device description
Neuromuscular Electrical Stimulator intended for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099058517020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509905851702015099058517020

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
987904356
Device count
1
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099058735004Slendertone Evolve Abs735735-50002021-03-26
15099058734007SLENDERTONE CoreFit Abs 87340734-50002019-05-29
15099058390012The Flex Belt System Controller3900390-50142016-09-24
15099058392016SLENDERTONE ABS 6392 (390, X10)0392-50202016-09-24
15099058396021The Flex Mini Accessory Pack3960396-50422016-09-24
15099058397011Slendertone Arms397 (390, X60)0397-50442016-09-24
15099058397028Flex Arms Accessory Pack3970397-50322016-09-24
15099058399015Slendertone Abs 7399 (390, X70)0399-50622016-09-24
15099058399022The Flex Belt399 (390, X70)0399-50602016-09-24
15099058412004Kneehab XP4120412-50012016-09-24
15099058439001Avivatens Pain Management439, 438, 4130439-50062016-09-24
15099058515019Slendertone Abs 35150515-50662016-09-24
15099058517013Slendertone Abs 5517 - US0517-50122016-09-24
15099058561009Slendertone Revive5610561-50122016-09-24
15099058570001Slendertone Connect5700570-50002016-09-24
05099058732013Slendertone Replacement Abdominal Toning Gel Pads732 / 7330706-96322020-07-06
00834536001077The Flex Belt Replacement Electrodes732 / 7330706-75412016-09-24
15099058716003Slendertone Replacement Bottom Toning Gel Pads7162016-09-24
15099058718007Slendertone Arm Toner Muscle Training System Gel Pads7182016-09-24
15099058719004Slendertone Unisex Replacement Gel Pads for Revive S57192016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128084AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03