FDA.reportPublic FDA data

The Flex Belt System Controller

Primary DI
15099058390012
Brand
The Flex Belt System Controller
Company
BIO-MEDICAL RESEARCH LIMITED
Model
390
Catalog number
0390-5014
Device description
Neuromuscular Electrical Stimulator Control Unit
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
15099058390012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509905839001215099058390012

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
987904356
Device count
1
Kit
true
Serial number
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
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
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
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNGX2026-06-24
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
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