The following data is part of a premarket notification filed by Pdg Product Design Group, Inc. with the FDA for Astrotilt Manual Wheelchair.
| Device ID | K061475 |
| 510k Number | K061475 |
| Device Name: | ASTROTILT MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | PDG PRODUCT DESIGN GROUP, INC. UNIT 102-366 E. KENT AVE. SOUTH Vancouver, Bc, CA V5x 4n6 |
| Contact | Nancy Balcom |
| Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-30 |
| Decision Date | 2006-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B829981 | K061475 | 000 |