ROBO— 510(k) K942508

Substantially Equivalent for Some Indications

Permobil AB

FDA 510(k) clearance K942508 for ROBO, Substantially Equivalent for Some Indications on 1994-11-07. Applicant: Permobil AB.

Clearance details

Applicant: Permobil AB
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1994-05-26
Decision date: 1994-11-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Timra, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.