The following data is part of a premarket notification filed by Parabasetec, Gmbh with the FDA for Paragolfer.
| Device ID | K060936 |
| 510k Number | K060936 |
| Device Name: | PARAGOLFER |
| Classification | Wheelchair, Standup |
| Applicant | PARABASETEC, GMBH 2247 JENNIFER LANE St. Paul, MN 55109 |
| Contact | William Jackson |
| Correspondent | William Jackson PARABASETEC, GMBH 2247 JENNIFER LANE St. Paul, MN 55109 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-05 |
| Decision Date | 2006-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04032767817948 | K060936 | 000 |
| 04032767402526 | K060936 | 000 |
| 04032767048397 | K060936 | 000 |
| 04064406193656 | K060936 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PARAGOLFER 79066956 3807159 Dead/Cancelled |
Otto Bock HealthCare GmbH 2009-02-23 |
![]() PARAGOLFER 76711427 4200403 Live/Registered |
Otto Bock HealthCare GmbH 2009-02-23 |