The following data is part of a premarket notification filed by Summit Harmar, Llc with the FDA for Pinnacle Stair Way Lift.
| Device ID | K091858 |
| 510k Number | K091858 |
| Device Name: | PINNACLE STAIR WAY LIFT |
| Classification | Transport, Patient, Powered |
| Applicant | SUMMIT HARMAR, LLC 5905 FAWN LANE Cleveland, OH 44144 |
| Contact | Edward Krol |
| Correspondent | Edward Krol SUMMIT HARMAR, LLC 5905 FAWN LANE Cleveland, OH 44144 |
| Product Code | ILK |
| CFR Regulation Number | 890.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817650023019 | K091858 | 000 |
| 00817650022432 | K091858 | 000 |
| 00817650022425 | K091858 | 000 |
| 00817650022418 | K091858 | 000 |
| 00817650022401 | K091858 | 000 |
| 00817650022265 | K091858 | 000 |
| 00817650022258 | K091858 | 000 |
| 00817650022241 | K091858 | 000 |
| 00817650022234 | K091858 | 000 |
| 00817650022227 | K091858 | 000 |
| 00817650022210 | K091858 | 000 |
| 00817650022449 | K091858 | 000 |
| 00817650022456 | K091858 | 000 |
| 00817650022463 | K091858 | 000 |
| 00817650023002 | K091858 | 000 |
| 00817650022937 | K091858 | 000 |
| 00817650022876 | K091858 | 000 |
| 00817650022869 | K091858 | 000 |
| 00817650022852 | K091858 | 000 |
| 00817650022517 | K091858 | 000 |
| 00817650022500 | K091858 | 000 |
| 00817650022494 | K091858 | 000 |
| 00817650022487 | K091858 | 000 |
| 00817650022470 | K091858 | 000 |
| 00817650022197 | K091858 | 000 |