The following data is part of a premarket notification filed by Guardian Products Co., Inc. with the FDA for Folding Wheelchair.
| Device ID | K915108 |
| 510k Number | K915108 |
| Device Name: | FOLDING WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | GUARDIAN PRODUCTS CO., INC. 12222 SHERMAN WAY North Hollywood, CA 91605 |
| Contact | Alvin R.ball |
| Correspondent | Alvin R.ball GUARDIAN PRODUCTS CO., INC. 12222 SHERMAN WAY North Hollywood, CA 91605 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-01-13 |