Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012113857

FEI Number

3012113857

Entity Name

SCS DIRECT INC.

City/State/Country

Shelton, CT, US

Establishment Address

14 Progress Dr, Shelton, CT 06484, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SCS Direct Inc. (Owner Number: 10062306)

Owner / Operator Contact Address

9 Trefoil Drive, Trumbull, CT 06611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Crutch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPR	Crutch	Physical Medicine	Class 1	890.3150	2020-01-10

Official Correspondent

Kristin Kery

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SCS Direct 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 3012113857. Last updated year: 2026. Please use registration number 3012113857 when referencing this establishment in official correspondence.