The following data is part of a premarket notification filed by Inno-health Technology, Inc. with the FDA for Aculife, Model Smw-01.
| Device ID | K051197 |
| 510k Number | K051197 |
| Device Name: | ACULIFE, MODEL SMW-01 |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | INNO-HEALTH TECHNOLOGY, INC. 8F-2, NO. 61 KUNG-YI ROAD SECTION 2 Taichung, TW 408 |
| Contact | Terry C Chiang |
| Correspondent | Terry C Chiang INNO-HEALTH TECHNOLOGY, INC. 8F-2, NO. 61 KUNG-YI ROAD SECTION 2 Taichung, TW 408 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-10 |
| Decision Date | 2006-03-28 |
| Summary: | summary |