The following data is part of a premarket notification filed by Summit Durable Medical Equipment, Inc. with the FDA for Summit Mechanical Wheelchair.
| Device ID | K946195 |
| 510k Number | K946195 |
| Device Name: | SUMMIT MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | SUMMIT DURABLE MEDICAL EQUIPMENT, INC. 12603 EXECUTIVE DR., SUITE 814 Stafford, TX 77477 |
| Contact | David Chung |
| Correspondent | David Chung SUMMIT DURABLE MEDICAL EQUIPMENT, INC. 12603 EXECUTIVE DR., SUITE 814 Stafford, TX 77477 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-02-09 |