Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006240003

FEI Number

3006240003

Entity Name

MYOMO, INC.

City/State/Country

Burlington, MA, US

Establishment Address

45 Blue Sky Dr Ste 101, Burlington, MA 01803, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MYOMO, INC. (Owner Number: 9100960)

Owner / Operator Contact Address

45 Blue Sky Drive, Suite 101, Burlington, MA 01803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MyoPro MARK MyoPro 2+ MARK2 MyoPro 2x MyoPro MARK MARK2 MyoPro 2x MyoPro 2+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2016-12-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2009-05-27

Official Correspondent

Dennis Shay

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MYOMO, INC.

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 3006240003. Last updated year: 2026. Please use registration number 3006240003 when referencing this establishment in official correspondence.