The following data is part of a premarket notification filed by Deka Research & Development Corp with the FDA for Next Generation Ibot.
| Device ID | K172601 |
| 510k Number | K172601 |
| Device Name: | Next Generation IBOT |
| Classification | Wheelchair, Stair Climbing |
| Applicant | DEKA Research & Development Corp 340 Commercial St. Manchester, NH 03101 |
| Contact | Roger Leroux |
| Correspondent | Roger Leroux DEKA Research & Development Corp 340 Commercial St. Manchester, NH 03101 |
| Product Code | IMK |
| CFR Regulation Number | 890.3890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-30 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857584008003 | K172601 | 000 |