Slendertone Arms 0397-5044

GUDID 15099058397011

Neuromuscular Electrical Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.

BIO-MEDICAL RESEARCH LIMITED

Transcutaneous electrical stimulation electrode

• Primary Device ID: 15099058397011
• NIH Device Record Key: 76a5f798-ae4f-4eb3-a8d7-77ef52da7655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slendertone Arms
• Version Model Number: 397 (390, X60)
• Catalog Number: 0397-5044
• Company DUNS: 987904356
• Company Name: BIO-MEDICAL RESEARCH 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: true
• 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	15099058397011 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

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