Stellar LEAP— 510(k) K163432
Substantially EquivalentPdg Product Design Group, Inc.
FDA 510(k) clearance K163432 for Stellar LEAP, Substantially Equivalent on 2017-06-27. Applicant: Pdg Product Design Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Pdg Product Design Group, Inc.
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vancouver, CA
Recent devices under product code IOR
view allMore clearances from Pdg Product Design Group, Inc.
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
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.