Gunnell, Inc.
United Statesfrom the FDA registration address FDA FEI 3009255757
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009255757
- Address
- 321 W 12th St, Elk City, OK, 73644
FDA recalls
2011
- 1 Nov 2011 Z-0863-2012 Unclassified (pre-2012) Terminated 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.
- 1 Nov 2011 Z-0864-2012 Unclassified (pre-2012) Terminated 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.
- 1 Nov 2011 Z-0865-2012 Unclassified (pre-2012) Terminated 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.
- 1 Nov 2011 Z-0866-2012 Unclassified (pre-2012) Terminated 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.
- 1 Nov 2011 Z-0867-2012 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Gunnell, Inc. have in the registry?
The registry currently lists 1 device for Gunnell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gunnell, Inc.'s devices?
Among its 1 most recently registered device, Gunnell, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Gunnell, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gunnell, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Gunnell, Inc.?
FDA recall records list 5 recalls initiated by Gunnell, Inc., the most recent initiated on 1 Nov 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Gunnell, Inc. in the registry?
The most recently registered devices listed for Gunnell, Inc. include REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM.