Reference Source

Nh Limited Narl Exclusive · 89-08 · HONG KONG SAR

For Nh Limited Narl Exclusive, import alert is 89-08; country is HONG KONG SAR; 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 2f 30 Haiphong Rd , Kowloon, HONG KONG SAR, verified against its source on 2026-09-30.

Firm
Nh Limited Narl Exclusive 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
HONG KONG SAR verified
Address
2f 30 Haiphong Rd , Kowloon, HONG KONG SAR 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Nh Limited Narl Exclusive Date Published : 11/15/2010 2f 30 Haiphong Rd , Kowloon, HONG KONG SAR

— 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

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