The following data is part of a premarket notification filed by Pdg Product Design Group, Inc with the FDA for Stellar Leap.
| Device ID | K163432 |
| 510k Number | K163432 |
| Device Name: | Stellar LEAP |
| Classification | Wheelchair, Mechanical |
| Applicant | PDG Product Design Group, Inc 103 - 318 East Kent Ave. South Vancouver, CA V5x4nc |
| Contact | Torr Brown |
| Correspondent | Georgiann Keyport Canopy Medical LLC 1160 Vierling Drive Shakopee, MN 55379 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B829221 | K163432 | 000 |