The following data is part of a premarket notification filed by E-teng Technology, Inc. with the FDA for E-teng Model Eor 1.
| Device ID | K122562 |
| 510k Number | K122562 |
| Device Name: | E-TENG MODEL EOR 1 |
| Classification | Wheelchair, Standup |
| Applicant | E-TENG TECHNOLOGY, INC. 16F-2 (16A), NO. 462, SEC. 2 CHONGDE RD, BEITUN DIST. Taichung, TW 406 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang E-TENG TECHNOLOGY, INC. 16F-2 (16A), NO. 462, SEC. 2 CHONGDE RD, BEITUN DIST. Taichung, TW 406 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859706005990 | K122562 | 000 |
| 00810058400017 | K122562 | 000 |
| 00810058400024 | K122562 | 000 |
| 00810058400031 | K122562 | 000 |
| 00810058400048 | K122562 | 000 |
| 00810058400055 | K122562 | 000 |
| 00810058400062 | K122562 | 000 |
| 00810058400079 | K122562 | 000 |
| 00859706005976 | K122562 | 000 |
| 00859706005983 | K122562 | 000 |
| 00810058400000 | K122562 | 000 |