Snug Seat, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Snug Seat, Inc. makes
Snug Seat, Inc. manufactures manual wheelchair models, including the PANTHER WHEELCHAIR for adults and the WIZARD PEDIATRIC WHEELCHAIR designed for children. These products are intended for mobility assistance in clinical and home settings.
The company’s wheelchairs are classified as Class I devices under FDA regulations and are supported by 510(k) clearance records. The manufacturer is based in the United States.
Catalogue
Panther Wheelchair Ref K982849
Regimes: 510(k) Registry: 510(k)Wizard Pediatric Wheelchair Ref K934560
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Snug Seat, Inc., the earliest on 2008-11-06 and the most recent on 2013-08-26. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 26 Aug 2013 Z-0503-2015 Class II Terminated The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
Full distribution text
- 26 Aug 2013 Z-0503-2015 Class II Terminated The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
2008
- 6 Nov 2008 Z-0651-2009 Unclassified (pre-2012) Terminated Breakage in the welds was discovered in a section of the chair frame.
Frequently asked questions
How many devices does Snug Seat, Inc. have in the registry?
The registry currently lists 2 devices for Snug Seat, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Snug Seat, Inc.'s devices?
Among its 2 most recently registered devices, Snug Seat, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Snug Seat, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Snug Seat, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Snug Seat, Inc.?
FDA recall records list 2 recalls initiated by Snug Seat, Inc., the most recent initiated on 26 Aug 2013. 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 Snug Seat, Inc. in the registry?
The most recently registered devices listed for Snug Seat, Inc. include PANTHER WHEELCHAIR and WIZARD PEDIATRIC WHEELCHAIR.