Sensiv

GUDID 00850033118117

Sensiv Multi-Channel Pain Relief TENs Unit

Acutens Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00850033118117
• NIH Device Record Key: bcaacfdb-6fc4-47a5-8fda-7d101c6a356a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensiv
• Version Model Number: SENTENSM
• Company DUNS: 051133165
• Company Name: Acutens Inc
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033118117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183288

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Sensiv]

• 00850033118162: Sensiv Circular Wrist Blood Pressure Monitor
• 00850033118155: Sensiv Upper Arm Digital Blood Pressure Monitor
• 00850033118148: Sensiv TENS Large Replacement Pads 2 pack
• 00850033118131: Sensiv TENS Small Replacement Pads 4 pairs
• 00850033118124: Sensiv Full-Body TENs Pain Relief Therapy with Foot Attachment
• 00850033118117: Sensiv Multi-Channel Pain Relief TENs Unit
• 00850033118100: Sensiv Easy Relief TENs Unit