The following data is part of a premarket notification filed by Electro Kinetic Technologies, Llc with the FDA for Breeze Electric Transport Chair Model 1025.
| Device ID | K111095 |
| 510k Number | K111095 |
| Device Name: | BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 |
| Classification | Wheelchair, Powered |
| Applicant | ELECTRO KINETIC TECHNOLOGIES, LLC W194N11301 MCCORMICK DRIVE Gemantown, WI 53022 |
| Contact | Raymond Erbe |
| Correspondent | Raymond Erbe ELECTRO KINETIC TECHNOLOGIES, LLC W194N11301 MCCORMICK DRIVE Gemantown, WI 53022 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B7981025G0 | K111095 | 000 |