PURPLE INNOVATION, LLC

FDA Device Registration & Listing · Mc Donough, GA, US · Registration 3009643016

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
3009643016
FEI Number
3009643016
Entity Name
PURPLE INNOVATION, LLC
City/State/Country
Mc Donough, GA, US
Establishment Address
1325 Highway 42 South, Mc Donough, GA 30253, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Purple Innovation, LLC (Owner Number: 10040794)
Owner / Operator Contact Address
4100 N. Chapel Ridge Rd. Suite 200, Lehi, UT 84043, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EquaGel Adjustable Protector Cushion EquaGel EquaGel General Cushion EquaGel Protector Cushion EquaPressure

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMP Cushion, Wheelchair Physical Medicine Class 1 890.3920 2012-05-18

Official Correspondent

James Larson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Purple Innovation, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009643016. Last updated year: 2026. Please use registration number 3009643016 when referencing this establishment in official correspondence.
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