Miwa Science Corp · 89-08 · JAPAN
For Miwa Science Corp · 89-08 · JAPAN, 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 JAPAN; product is NARL 517 MS (Beauty Equipment Massager) | NARL 517 MS (Beauty Equipment Massager); product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat; date published is 11/15/2010; address is 2 4 2 Azaminominami , Kanagawa, JAPAN, verified against its source on 2026-09-16.
- Firm
- Miwa Science Corp 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
- JAPAN verified
- Address
- 2 4 2 Azaminominami , Kanagawa, JAPAN verified
- Date published
- 11/15/2010 verified
- Product code
- 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat each item verified
- Product
- NARL 517 MS (Beauty Equipment Massager) | NARL 517 MS (Beauty Equipment Massager) each item verified
- FDA notes
- Class III | Class III each item verified
What the source says
Miwa Science Corp Date Published : 11/15/2010 2 4 2 Azaminominami , Kanagawa, JAPAN 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 11/15/2010 Desc: NARL 517 MS (Beauty Equipment Massager) Notes: Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 11/15/2010 Desc: NARL 517 MS (Beauty Equipment Massager) 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.