Reference Source

Homesquare International Ltd · 89-08 · HONG KONG SAR

For Homesquare International Ltd · 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 ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device; product code is 89 G - - ZC Stimulator, Neuromuscular, Implanted | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 01/30/2019; address is Ever Gain Plaza Tower 2 , 88 Container Port Road , Kwai Chung, New Territories HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Homesquare International 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
HONG KONG SAR verified
Address
Ever Gain Plaza Tower 2 , 88 Container Port Road , Kwai Chung, New Territories HONG KONG SAR verified
Date published
01/30/2019 verified
Product code
89 G - - ZC Stimulator, Neuromuscular, Implanted | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
Product
ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device | ABGYMNIC Electronic Gymnastic Device each item verified
FDA notes
6/27/2002 | 6/27/2002 | 6/27/2002 | 6/27/2002 | 6/27/2002 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

Homesquare International Ltd Date Published : 01/30/2019 Ever Gain Plaza Tower 2 , 88 Container Port Road , Kwai Chung, New Territories HONG KONG SAR 89 G - - ZC Stimulator, Neuromuscular, Implanted Date Published: 01/30/2019 Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/2002 89 I - - PF Stimulator, Muscle, Powered Date Published: 01/30/2019 Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/2002 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/30/2019 Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/2002 89 L - - YG Massager, Therapeutic, Manual Date Published: 01/30/2019 Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/2002 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 01/30/2019 Desc: ABGYMNIC Electronic Gymnastic Device Notes: 6/27/2002

accessdata.fda.gov, retrieved 2026-09-15

Source

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