The following data is part of a premarket notification filed by Karma Medical Products Co., Ltd. with the FDA for Karma Manual Wheelchair, Models S-ergo 305 And S-ergo 105.
| Device ID | K062309 |
| 510k Number | K062309 |
| Device Name: | KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 |
| 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 | 2006-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873857333 | K062309 | 000 |
| 04719873854882 | K062309 | 000 |
| 04719873856961 | K062309 | 000 |
| 04719873857012 | K062309 | 000 |
| 04719873857067 | K062309 | 000 |
| 04719873857098 | K062309 | 000 |
| 04719873857128 | K062309 | 000 |
| 04719873857159 | K062309 | 000 |
| 04719873857166 | K062309 | 000 |
| 04719873857197 | K062309 | 000 |
| 04719873857227 | K062309 | 000 |
| 04719873857234 | K062309 | 000 |
| 04719873857241 | K062309 | 000 |
| 04719873857258 | K062309 | 000 |
| 04719873857272 | K062309 | 000 |
| 04719873854875 | K062309 | 000 |