Apollo Duet (Model : APD-4000)

Massager, Vacuum, Radio Frequency Induced Heat

Weero Co.

The following data is part of a premarket notification filed by Weero Co. with the FDA for Apollo Duet (model : Apd-4000).

Pre-market Notification Details

Device IDK212253
510k NumberK212253
Device Name:Apollo Duet (Model : APD-4000)
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant Weero Co. A605 Venture Valley II, 142-10, Saneop-ro 156 Beon-gil Gwonseon-gu Suwon-si,  KR 16648
ContactJimin Han
CorrespondentEunice Cho
Weero Co. A605 Venture Valley II, 142-10, Saneop-ro 156 Beon-gil Gwonseon-gu Suwon-si,  KR 16648
Product CodePBX  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-19
Decision Date2022-08-25

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