The following data is part of a premarket notification filed by Karma Medical Products Co., Ltd. with the FDA for Karma Manual Wheelchair, Model Budget 800.
| Device ID | K062311 |
| 510k Number | K062311 |
| Device Name: | KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 |
| Classification | Wheelchair, Mechanical |
| Applicant | KARMA MEDICAL PRODUCTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen KARMA MEDICAL PRODUCTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-10-04 |
| Summary: | summary |