Slendertone Replacement Bottom and Thigh Toning Pa 0708-8723

GUDID 05099058708001

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation electrode
Primary Device ID05099058708001
NIH Device Record Key080f7914-d5bb-4c90-a31d-f7bb95cc4b4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlendertone Replacement Bottom and Thigh Toning Pa
Version Model Number706 / 708
Catalog Number0708-8723
Company DUNS987904356
Company NameBIO-MEDICAL RESEARCH LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS105099058708001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by BIO-MEDICAL RESEARCH LIMITED

15099058735004 - Slendertone Evolve Abs2021-04-05 The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulatio
05099058732013 - Slendertone Replacement Abdominal Toning Gel Pads2020-07-14
15099058734007 - SLENDERTONE CoreFit Abs 82019-10-23 The SLENDERTONE CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimula
15099058390012 - The Flex Belt System Controller2019-10-23 Neuromuscular Electrical Stimulator Control Unit
15099058392016 - SLENDERTONE ABS 62019-10-23 Neuromuscular Electrical Stimulator intended for the improvement of abdominal muscle tone for the strengthening of the abdominal
15099058396021 - The Flex Mini Accessory Pack2019-10-23 FLEX MINI M ACCESSORY US
15099058397011 - Slendertone Arms2019-10-23 Neuromuscular Electrical Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance o
15099058397028 - Flex Arms Accessory Pack2019-10-23 FLEX ARMS PREMIUM M ACCESSORY US

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.