RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT— 510(k) K940851
Substantially Equivalent for Some IndicationsRedman, Inc.
FDA 510(k) clearance K940851 for RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT, Substantially Equivalent for Some Indications on 1995-02-03. Applicant: Redman, Inc.. Device class: 2.
Clearance details
- Applicant
- Redman, Inc.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code ITI
view allMore clearances from Redman, Inc.
view allAdverse 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.