Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016856381

FEI Number

3012640203

Entity Name

Hinge Health Inc.

City/State/Country

San Francisco, CA, US

Establishment Address

455 Market Street, Suite 700, San Francisco, CA 94105, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Hinge Health Inc. (Owner Number: 10082971)

Owner / Operator Contact Address

455 Market Street, Suite 700, San Francisco, CA 94105, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K254216

PMA Number

N/A

All Registered Proprietary Names

ENSO Enso Enso for Migraine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-10-18
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-10-18
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-12-28
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-12-28
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2026-04-20

Official Correspondent

Charles Han

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hinge Health Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016856381. Last updated year: 2026. Please use registration number 3016856381 when referencing this establishment in official correspondence.