Reference Source

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

For Nh Limited Narl Exclusive · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 2026-09-16.

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 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

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