The following data is part of a premarket notification filed by Taiwan Armada Enterprise Co., Ltd. with the FDA for Biotech Manual Wheelchair A2000 Super Motive Wheelchair.
| Device ID | K020284 |
| 510k Number | K020284 |
| Device Name: | BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | TAIWAN ARMADA ENTERPRISE CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen TAIWAN ARMADA ENTERPRISE CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-02-08 |