Enso Model 2

GUDID 00195893670284

Nerve stimulator for pain relief

Hinge Health, Inc.

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00195893670284
• NIH Device Record Key: d2a8cdd3-7a5e-4d07-9ce7-5a6b87ad6bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enso Model 2
• Version Model Number: 100-365
• 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
• 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	00195893670284 [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: 2022-05-09
• Device Publish Date: 2022-05-01

Devices Manufactured by Hinge Health, Inc.

• 00850045950026 - Enso: 2024-01-11 Nerve stimulator for pain relief (manufactured in Malaysia)
• 00850045950033 - Enso: 2023-06-15 Nerve stimulator for pain relief (stand-alone unit)
• 00850045950002 - Enso: 2022-09-28 Nerve stimulator for pain relief
• 00850045950019 - Enso: 2022-09-28 Nerve stimulator for pain relief
• 00195893670284 - Enso Model 2: 2022-05-09Nerve stimulator for pain relief
• 00195893670284 - Enso Model 2: 2022-05-09 Nerve stimulator for pain relief
• 00195893606580 - Enso Model 1: 2022-02-01 Nerve stimulator for pain relief