Taiwan Creations · 89-08 · TAIWAN
For Taiwan Creations · 89-08 · TAIWAN, import alert is 89-08; 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)"; country is TAIWAN; 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 2026-09-16.
- 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 84 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Alpha-wave Healthtronic; MuscleStimulator and Slimming Device Notes: Class III
— 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.