WALK-A-CYCLE— 510(k) K820711
Substantially EquivalentWalk-A-Cycle Division
FDA 510(k) clearance K820711 for WALK-A-CYCLE, Substantially Equivalent on 1982-04-08. Applicant: Walk-A-Cycle Division. Device class: 1.
Clearance details
- Applicant
- Walk-A-Cycle Division
- Product code
- Code ITJ
- Device class
- Class 1
- Regulation
- 21 CFR 890.3825
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code ITJ
view allAdverse events under product code ITJ
product code ITJ- Death
- 8
- Injury
- 571
- Other
- 2
- Total
- 581
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.