Slendertone 735-5000

GUDID 05391546170018

The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

Bio-Medical Science & Technology LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 05391546170018
• NIH Device Record Key: 8c279678-a245-4c0f-9c2f-6b1bcf015c08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slendertone
• Version Model Number: Type 735
• Catalog Number: 735-5000
• Company DUNS: 986121542
• Company Name: Bio-Medical Science & Technology LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391546170018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203513

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-11
• Device Publish Date: 2024-10-03

Devices Manufactured by Bio-Medical Science & Technology LIMITED

• 05391546170018 - Slendertone: 2024-10-11The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
• 05391546170018 - Slendertone: 2024-10-11 The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulatio
• 05391546170032 - Slendertone Replacement Abdominal Toning Gel Pads: 2024-10-11 Replacement Abdominal Toning Gel Pads