INSIGHTFUL PRODUCTS

FDA Device Registration & Listing · Falmouth, ME, US · Registration 3005526310

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005526310
FEI Number
3005526310
Entity Name
INSIGHTFUL PRODUCTS
City/State/Country
Falmouth, ME, US
Establishment Address
367 Us Route 1, Falmouth, ME 04105, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Insightful Products (Owner Number: 10058205)
Owner / Operator Contact Address
367 US Route 1, Suite 5-S, Falmouth, ME 04105, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Step-Smart

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHI Orthosis, Foot Drop Physical Medicine Class 1 890.3475 2022-01-17

Official Correspondent

Ian Engelman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Insightful Products
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 3005526310. Last updated year: 2026. Please use registration number 3005526310 when referencing this establishment in official correspondence.
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