Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009809406

FEI Number

3009809406

Entity Name

BACK ON TRACK BOT LLC

City/State/Country

Pottstown, PA, US

Establishment Address

350 Circle of Progress Drive, Pottstown, PA 19464, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Back on Track BOT LLC (Owner Number: 10046578)

Owner / Operator Contact Address

350 Circle of Progress Drive, Pottstown, PA 19464, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back on Track Back on Track

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2014-04-09
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2021-12-01

Official Correspondent

James Ruder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Back on Track BOT LLC

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 3009809406. Last updated year: 2026. Please use registration number 3009809406 when referencing this establishment in official correspondence.