Miwa Science Corp · 89-08 · JAPAN
For Miwa Science Corp, import alert is 89-08; country is JAPAN; 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html