AVIVO LIFE, LLC

FDA Device Registration & Listing · Rockville, MD, US · Registration 3044085583

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
3044085583
FEI Number
3044085583
Entity Name
AVIVO LIFE, LLC
City/State/Country
Rockville, MD, US
Establishment Address
1395 Piccard Dr, Suite 200 - M18, Rockville, MD 20850, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Avivo Life, LLC (Owner Number: 10095502)
Owner / Operator Contact Address
1395 Piccard Dr, Suite 200 - M18, Rockville, MD 20850, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Avivo Life Wheelchair K051481 Avivo Life Commode & Wheelchair Attachments Avivo Life Chair with Casters Avivo Life Wheelchair Accessories Avivo Life Mechanical Walker and Rollator Avivo Life Tips & Pads for Cane/Crutch/Walker Avivo Life Wheelchair K051482 Avivo Life Crutch Avivo Life Cane Avivo Life Mechanical Table

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2026-03-20
INB Attachment, Commode, Wheelchair Physical Medicine Class 1 890.3920 2026-03-20
INM Chair, With Casters Physical Medicine Class 1 890.3100 2026-03-20
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2026-03-20
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2026-03-20
INP Tips And Pads, Cane, Crutch And Walker Physical Medicine Class 1 890.3790 2026-03-20
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2026-03-20
IPR Crutch Physical Medicine Class 1 890.3150 2026-03-20
IPS Cane Physical Medicine Class 1 890.3075 2026-03-20
INW Table, Mechanical Physical Medicine Class 1 890.3750 2026-03-20

Official Correspondent

George Ju

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avivo Life, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02
K832685 Health America WHEELCHAIR-VARIOUS MODELS 1983-09-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2015 Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056 1
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013 Winco Mfg., LLC 1
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Z-0032-2013 Winco Mfg., LLC 1
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044085583. Last updated year: 2026. Please use registration number 3044085583 when referencing this establishment in official correspondence.
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