Enso Model 1

GUDID 00195893606580

Nerve stimulator for pain relief

Hinge Health, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00195893606580
• NIH Device Record Key: 72ff8c90-7303-4108-bce8-0e5eda73694f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enso Model 1
• Version Model Number: 100-001
• 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
• 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	00195893606580 [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: 2022-02-01
• Device Publish Date: 2022-01-24

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: 2022-05-09 Nerve stimulator for pain relief
• 00195893606580 - Enso Model 1: 2022-02-01Nerve stimulator for pain relief
• 00195893606580 - Enso Model 1: 2022-02-01 Nerve stimulator for pain relief