The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for P.r.o. Cg Manual Wheelchair.
| Device ID | K151893 |
| 510k Number | K151893 |
| Device Name: | P.R.O. CG Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | FREEDOM DESIGNS, INC. 2241 MADERA ROAD Simi Valley, CA 93065 |
| Contact | Nancy F Schmidt |
| Correspondent | Nancy F Schmidt FREEDOM DESIGNS, INC. 2241 MADERA ROAD Simi Valley, CA 93065 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-10 |
| Decision Date | 2015-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447101253 | K151893 | 000 |