The following data is part of a premarket notification filed by Pdg Product Design Group, Inc. with the FDA for Fuze Mechanical Wheelchair, Models T20 And T50.
| Device ID | K063736 |
| 510k Number | K063736 |
| Device Name: | FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 |
| Classification | Wheelchair, Mechanical |
| Applicant | PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-18 |
| Decision Date | 2007-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B829261 | K063736 | 000 |
| B829171 | K063736 | 000 |
| B829161 | K063736 | 000 |
| B829151 | K063736 | 000 |