DeviceClearance

3-D PASSIVE MOBILIZER— 510(k) K834360

Substantially Equivalent

3-D Orthopedic, Inc.

FDA 510(k) clearance K834360 for 3-D PASSIVE MOBILIZER, Substantially Equivalent on 1984-01-13. Applicant: 3-D Orthopedic, Inc..

Clearance details

Applicant
3-D Orthopedic, Inc.
Product code
Code ISD
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ISD

product code ISD
Other
2
Total
2

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.