The following data is part of a premarket notification filed by Permobil A.b. with the FDA for Electro.
| Device ID | K041219 |
| 510k Number | K041219 |
| Device Name: | ELECTRO |
| Classification | Wheelchair, Powered |
| Applicant | PERMOBIL A.B. BOX 120 Timra, SE S-861 23 |
| Contact | Jan' Astrom |
| Correspondent | Jan' Astrom PERMOBIL A.B. BOX 120 Timra, SE S-861 23 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17330818889420 | K041219 | 000 |