The following data is part of a premarket notification filed by Whill, Inc. with the FDA for Whill Model M.
| Device ID | K153543 |
| 510k Number | K153543 |
| Device Name: | WHILL Model M |
| Classification | Wheelchair, Powered |
| Applicant | WHILL, INC. 285 OLD COUNTY RD, SUITE 6 San Carlos, CA 94070 |
| Contact | Terese Bogucki |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866917000201 | K153543 | 000 |