The following data is part of a premarket notification filed by Maxhealth Corp. with the FDA for Maxhealth Wheelchair, Model He-8631, He-8621, He-8651.
| Device ID | K001252 |
| 510k Number | K001252 |
| Device Name: | MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 |
| Classification | Wheelchair, Mechanical |
| Applicant | MAXHEALTH CORP. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward MAXHEALTH CORP. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-06-12 |