The following data is part of a premarket notification filed by Golden Technologies, Inc. with the FDA for Alante, Battery Operated Power Wheelchair.
| Device ID | K011153 |
| 510k Number | K011153 |
| Device Name: | ALANTE, BATTERY OPERATED POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Contact | Fred Kiwak |
| Correspondent | Fred Kiwak GOLDEN TECHNOLOGIES, INC. 401 BRIDGE ST. Old Forge, PA 18518 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B247GP209 | K011153 | 000 |
| B247GP208 | K011153 | 000 |
| B247GP164 | K011153 | 000 |