The following data is part of a premarket notification filed by Quest Enabling Designs Ltd. with the FDA for Bobcat Dx.
| Device ID | K970543 |
| 510k Number | K970543 |
| Device Name: | BOBCAT DX |
| Classification | Wheelchair, Standup |
| Applicant | QUEST ENABLING DESIGNS LTD. ABILITY HOUSE, 242 GOSPORT RD Fareham, Hampshire, GB Po 16 Oss |
| Contact | Naheed Akhtar |
| Correspondent | Naheed Akhtar QUEST ENABLING DESIGNS LTD. ABILITY HOUSE, 242 GOSPORT RD Fareham, Hampshire, GB Po 16 Oss |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-06-26 |
| Summary: | summary |