The following data is part of a premarket notification filed by Ki Mobility Llc with the FDA for Catalysy.
| Device ID | K062660 |
| 510k Number | K062660 |
| Device Name: | CATALYSY |
| Classification | Wheelchair, Mechanical |
| Applicant | KI MOBILITY LLC 4925 COYE DRIVE SUITE D Stevens Point, WI 54481 |
| Contact | Douglas Munsey |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2006-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850013379132 | K062660 | 000 |
| 00850013379309 | K062660 | 000 |
| 00850013379316 | K062660 | 000 |
| 00850013379293 | K062660 | 000 |
| 00850013379262 | K062660 | 000 |
| 00850013379019 | K062660 | 000 |
| 00850013379026 | K062660 | 000 |
| 00850013379033 | K062660 | 000 |
| 00850013379040 | K062660 | 000 |
| 00850013379057 | K062660 | 000 |
| 00850013379064 | K062660 | 000 |
| 00850013379071 | K062660 | 000 |
| 00850013379088 | K062660 | 000 |
| 00850013379095 | K062660 | 000 |
| 00850013379101 | K062660 | 000 |
| 00850013379118 | K062660 | 000 |
| 00850013379125 | K062660 | 000 |
| 00850013379323 | K062660 | 000 |