Reference Source

Guangzhou Nouzi Beauty Equipment Co Ltd · 89-08 · CHINA

For Guangzhou Nouzi Beauty Equipment Co Ltd, import alert is 89-08; country is CHINA; 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 Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device); product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - SA Massager, Therapeutic, Electric; date published is 08/13/2013; address is No.23 Ziyuan Street , Guangzhou, CHINA, verified against its source on 2026-09-30.

Firm
Guangzhou Nouzi Beauty Equipment Co Ltd 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
CHINA verified
Address
No.23 Ziyuan Street , Guangzhou, CHINA verified
Date published
08/13/2013 verified
Product code
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device) | Body Relaxing Machine (weight loss device) each item verified
FDA notes
Class II | Class II | Class II | Class II 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

Guangzhou Nouzi Beauty Equipment Co Ltd Date Published : 08/13/2013 No.23 Ziyuan Street , Guangzhou, CHINA

— 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 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 08/13/2013 Desc: Body Relaxing Machine (weight loss device) Notes: Class II 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 08/13/2013 Desc: Body Relaxing Machine (weight loss device) Notes: Class II 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 08/13/2013 Desc: Body Relaxing Machine (weight loss device) Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 08/13/2013 Desc: Body Relaxing Machine (weight loss device) Notes: Class II

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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