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510(k) Data Aggregation
K Number
K203513Device Name
SLENDERTONE Evolve Abs, Type 735
Manufacturer
Date Cleared
2021-02-10
(72 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Bio-Medical Research Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
Device Description
The SLENDERTONE® Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains twelve pre-installed programs.
The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
The SLENDERTONE® Evolve Abs, Type 735 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.
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K Number
DEN170049Device Name
Innovo
Manufacturer
Date Cleared
2018-11-06
(414 days)
Product Code
Regulation Number
876.5330Why did this record match?
Applicant Name (Manufacturer) :
Bio-Medical Research Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
The Innovo is indicated for prescription use only.
Device Description
The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.
The Innovo is comprised of the following main components, along with accessories:
- Controller
- Body Garments (right and left)
- Gel Pads (8 surface electrodes)
- Battery Charger
- Lead Wire
- Neck Strap
The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.
The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.
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K Number
K180688Device Name
SLENDERTONE CoreFit Abs 8, Type 734
Manufacturer
Date Cleared
2018-10-25
(224 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Bio-Medical Research Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
Device Description
The SLENDERTONE® CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains ten pre-installed programs. The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
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K Number
K161974Device Name
SLENDERTONE® Connect Abs, Type 570
Manufacturer
Date Cleared
2016-11-01
(106 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Bio-Medical Research Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SLENDERTONE® Connect Abs, Type 570 is 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.
Device Description
The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.
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K Number
K151903Device Name
Slendertone connect Abs
Manufacturer
Date Cleared
2015-11-06
(119 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SLENDERTONE® connect Abs is 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. The SLENDERTONE® connect Abs, Type 570 is intended for over-the-counter use.
Device Description
The SLENDERTONE® Connect Abs, Type 570 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains one pre-installed program called 'Essential Toning'.
The SLENDERTONE® Connect Abs incorporates a Bluegiga BLE113 Bluetooth module to enable wireless communication and can be paired with a Bluetooth enabled iOS smart device running a Slendertone Connect iOS App, available from the Apple App store. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.
The control unit is connected to the abdominal belt garment via an 8-pin interface. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. These controls remain active while the control unit is wirelessly paired with a smart device and can be used in the event of loss of Bluetooth connection. The SLENDERTONE® connect Abs contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and bluetooth activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
The SLENDERTONE® Connect Abs, Type 570 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.
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