The following data is part of a premarket notification filed by Inno-health Technology, Inc. with the FDA for Electro-acupuncture: Aculife/model Idoc-01.
| Device ID | K091933 |
| 510k Number | K091933 |
| Device Name: | ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-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 Chang |
| Correspondent | Terry C Chang 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2010-04-02 |
| Summary: | summary |