The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for Spectrum Spirit.
| Device ID | K983763 |
| 510k Number | K983763 |
| Device Name: | SPECTRUM SPIRIT |
| Classification | Wheelchair, Mechanical |
| Applicant | FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065 |
| Contact | Ginny S Maloco |
| Correspondent | Ginny S Maloco FREEDOM DESIGNS, INC. 2241 MADERA RD. 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 | 1998-10-26 |
| Decision Date | 1998-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447101376 | K983763 | 000 |