Enso

GUDID 00850045950019

Nerve stimulator for pain relief

Hinge Health, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00850045950019
• NIH Device Record Key: 6bc3412d-69e2-4dbd-90a5-b66e1e75f5f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enso
• Version Model Number: M2
• Company DUNS: 080601423
• Company Name: Hinge Health, 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: true
• Lot Batch: false
• Serial Number: true
• 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: true

Customer Support Contacts

• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com
• Phone: 855-902-2777
• Email: help@hingehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045950019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160052

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Enso]

• 00850045950019: Nerve stimulator for pain relief
• 00850045950002: Nerve stimulator for pain relief
• 00850045950033: Nerve stimulator for pain relief (stand-alone unit)
• 00850045950026: Nerve stimulator for pain relief (manufactured in Malaysia)
• 00850045950064: Nerve stimulator for pain relief (manufactured in Malaysia) - 2 std., 1 back gel pad
• 00850045950057: Nerve stimulator for pain relief (manufactured in Malaysia) - 2 back, 1 std gel pad