UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR— 510(k) K932786
Substantially Equivalent for Some IndicationsNew Abilities Systems, Inc.
FDA 510(k) clearance K932786 for UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR, Substantially Equivalent for Some Indications on 1994-03-28. Applicant: New Abilities Systems, Inc..
Clearance details
- Applicant
- New Abilities Systems, Inc.
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Mount View, CA, US
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.