FDA.reportPublic FDA data

Slendertone Connect

Primary DI
15099058570001
Brand
Slendertone Connect
Company
BIO-MEDICAL RESEARCH LIMITED
Model
570
Catalog number
0570-5000
Device description
Neuromuscular Electrical Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated 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
15099058570001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509905857000115099058570001

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
15099058517020Slendertone Abs 5517 - US0517-50102016-09-24
15099058561009Slendertone Revive5610561-50122016-09-24
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

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Primary DI, Brand, Company table
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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
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00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
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00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
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00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
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