The following data is part of a premarket notification filed by Pdg Product Design Group, Inc. with the FDA for Eclipse 400 Manually Operated Wheelcair.
| Device ID | K971389 |
| 510k Number | K971389 |
| Device Name: | ECLIPSE 400 MANUALLY OPERATED WHEELCAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | PDG PRODUCT DESIGN GROUP, INC. 9165 SHAUGHNESSY ST., Vancouver,british Columbia, CA V6p 6r9 |
| Contact | Phil Mundy |
| Correspondent | Phil Mundy PDG PRODUCT DESIGN GROUP, INC. 9165 SHAUGHNESSY ST., Vancouver,british Columbia, CA V6p 6r9 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1997-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B829111 | K971389 | 000 |
| B829991 | K971389 | 000 |