The following data is part of a premarket notification filed by Mada Medical Products, Inc. with the FDA for Wheelchair, Mechanical Series Model 3100.
| Device ID | K002943 |
| 510k Number | K002943 |
| Device Name: | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 |
| Classification | Wheelchair, Mechanical |
| Applicant | MADA MEDICAL PRODUCTS, INC. 625 WASHINGTON AVE. Carlstadt, NJ 07072 |
| Contact | Jeffery W Adam |
| Correspondent | Jeffery W Adam MADA MEDICAL PRODUCTS, INC. 625 WASHINGTON AVE. Carlstadt, NJ 07072 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-21 |
| Decision Date | 2000-10-23 |