Taiwan Creations · 89-08 · TAIWAN
For Taiwan Creations, import alert is 89-08; country is TAIWAN; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Alpha-wave Healthtronic; MuscleStimulator and Slimming Device; product code is 84 B - - WK Stimulator, Electro-Acupuncture; date published is 03/08/2011; address is 112 Chung Shan Rd , Taipei, TAIWAN, verified against its source on 2026-09-30.
- Firm
- Taiwan Creations verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- TAIWAN verified
- Address
- 112 Chung Shan Rd , Taipei, TAIWAN verified
- Date published
- 03/08/2011 verified
- Product code
- 84 B - - WK Stimulator, Electro-Acupuncture verified
- Product
- Alpha-wave Healthtronic; MuscleStimulator and Slimming Device verified
- FDA notes
- Class III verified
What the source says
Taiwan Creations Date Published : 03/08/2011 112 Chung Shan Rd , Taipei, TAIWAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
84 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.