GUNNELL, Inc.

Elk City, OK, US

GUNNELL, Inc. appears in FDA device records in Elk City, OK. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 6 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 6
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to GUNNELL, 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.

CHENICA INC.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for GUNNELL, Inc. in 2012.

Clearances by year, as a table

510(k) clearance decisions for GUNNELL, Inc., by decision year
Year	Clearances
2012	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K111636	REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM	IOR	Substantially Equivalent	2012-04-03

Registered establishments

FDA registered establishments for GUNNELL, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009255757	3009255757	GUNNELL, Inc.	321 W 12th St, Elk City, OK 73644 US	2026	KNN

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0809-2013	Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.	The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).	Class II	2013-01-18	Terminated
Z-0867-2012	Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC Platform Chair Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.	Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic recline would not hold a firm position, or as described by users, the back support or canes were spongy.		2011-11-01	Terminated
Z-0866-2012	Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.	Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.		2011-11-01	Terminated
Z-0865-2012	Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.	Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.		2011-11-01	Terminated
Z-0864-2012	Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Tough and Tilt (TNT). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.	Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.		2011-11-01	Terminated
Z-0863-2012	Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.	Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position, or as described by users, the back support or canes were spongy in the Rehab Tough and Tilt (TNT), Bariatric Rehab Tough and Tilt (BTNT), Rehab Recline and Mobility (RAM), Bariatric Rehab Recline and Mobility (BRAM), and Rehab Kidster.		2011-11-01	Terminated

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