R82 Inc.

Charlotte, NC, US

R82 INC. appears in FDA device records in Charlotte, NC. FDA records list 2 510(k) clearances between 1994-01-07 and 1998-10-05, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to R82 Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Snug Seat, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for R82 Inc. between 1994 and 1998. The busiest year on record is 1994, with 1. The most recent is 1998, with 1.

Clearances by year, as a table

510(k) clearance decisions for R82 Inc., by decision year
Year	Clearances
1994	1
1998	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K982849	PANTHER WHEELCHAIR	IOR	Substantially Equivalent	1998-10-05
K934560	WIZARD PEDIATRIC WHEELCHAIR	IOR	Substantially Equivalent	1994-01-07

Registered establishments

FDA registered establishments for R82 Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1053060	1053060	R82 INC.	2101 Nevada Blvd, Charlotte, NC 28273 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

IORWheelchair, Mechanical

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0503-2015	Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.	The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.	Class II	2013-08-26	Terminated
Z-0651-2009	High-low:x frame for the x:panda mechanical chair.	Breakage in the welds was discovered in a section of the chair frame.		2008-11-06	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain