The following data is part of a premarket notification filed by Maxhealth Corp. with the FDA for Maxhealth Mechanical Wheelchair, K1.
| Device ID | K070176 |
| 510k Number | K070176 |
| Device Name: | MAXHEALTH MECHANICAL WHEELCHAIR, K1 |
| Classification | Wheelchair, Mechanical |
| Applicant | MAXHEALTH CORP. NO. 58, FU-CHIUN ST. Hsin-chu City,, TW |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min MAXHEALTH CORP. 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 | 2007-01-18 |
| Decision Date | 2007-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383246413 | K070176 | 000 |
| 00616784023014 | K070176 | 000 |
| 00616784022918 | K070176 | 000 |
| 00616784022819 | K070176 | 000 |
| 00616784022710 | K070176 | 000 |
| 00616784022611 | K070176 | 000 |
| 00616784022512 | K070176 | 000 |
| 00616784022413 | K070176 | 000 |
| 00616784022314 | K070176 | 000 |
| 00616784022215 | K070176 | 000 |
| 00616784022116 | K070176 | 000 |
| 00616784023113 | K070176 | 000 |
| 00616784023519 | K070176 | 000 |
| 00616784024516 | K070176 | 000 |
| 00616784025513 | K070176 | 000 |
| 00616784025414 | K070176 | 000 |
| 00616784027715 | K070176 | 000 |
| 00616784027616 | K070176 | 000 |
| 00616784027517 | K070176 | 000 |
| 00616784027418 | K070176 | 000 |
| 00616784023410 | K070176 | 000 |
| 00616784023311 | K070176 | 000 |
| 00616784024813 | K070176 | 000 |
| 00616784024714 | K070176 | 000 |
| 00616784022017 | K070176 | 000 |