Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010817595

FEI Number

3010817595

Entity Name

MODUS HEALTH, LLC

City/State/Country

Mountlake Ter, WA, US

Establishment Address

6100 219th St Sw Ste 480, Mountlake Ter, WA 98043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Modus Health (Owner Number: 10046601)

Owner / Operator Contact Address

6100 219th St Sw Ste 480, Mountlake Terrace, WA 98043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StepWatch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	Class 2	890.1925	2014-04-12

Official Correspondent

Teri Chou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Modus Health

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010817595. Last updated year: 2026. Please use registration number 3010817595 when referencing this establishment in official correspondence.