Sensiv

GUDID 00850033118100

Sensiv Easy Relief TENs Unit

Acutens Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00850033118100
• NIH Device Record Key: 7a9eb32a-f745-46db-92f2-7582e3399bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensiv
• Version Model Number: SENTENSE
• 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	00850033118100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181728

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: 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