Class 2 Device Recall Bemer Classic Set | 合法醫療器材資訊網
2021年2月10日—Arecordinthisdatabaseiscreatedwhenafirminitiatesacorrectionorremovalaction.TherecordisupdatediftheFDAidentifiesaviolationand ...
References Related Medical Device Recalls (www.accessdata.fda.gov) K151834 (www.accessdata.fda.gov) Stimulator, muscle, powered, for muscle conditioning (www.accessdata.fda.gov) NGX (www.accessdata.fda.gov) TPLC Device Report (www.accessdata.fda.gov) medical device recalls (www.fda.gov) Code of Federal Regulations (CFR) Title 21 §7.55 (www.accessdata.fda.gov) 510(K)s with Product Code = NGX and Original Applicant = BEMER Int. AG (www.accessdata.fda.gov) Class 2 Device Recall Bemer Classic Set, Bemer ProSet ...
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510(k) Premarket Notification | 合法醫療器材資訊網
2017年2月22日 — Super Search Devices@FDA 6 ... for muscle conditioning22. 510(k) Number, K151834. Device Name, BEMER Classic Set, BEMER Pro-Set. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
FDA, U.S. Food and Drug Administration. U.S. Food & Drug ... 1 to 2 of 2 Results ProductCode: NGX Applicant: BEMER Int. AG Decision Date To: 05/25/2021 ... Read More
BEMER | 合法醫療器材資訊網
2017年2月22日 — Trade/Device Name: BEMER Classic Set, BEMER Pro-Set ... Please be advised that FDA's issuance of a substantial equivalence determination ... Read More
BEMER Introductory Video FDA Approved PEMF (Pulsed ... | 合法醫療器材資訊網
BEMER is an FDA registered consumer medical device that, during an 8-minute session, sends a low level ... Read More
BEMER Life | Better Circulation | 合法醫療器材資訊網
For more than 20 years, the benefits of BEMER have impacted millions of people around the world. BEMER is an FDA Class II cleared consumer medical device ... Read More
BEMER Therapy: Uses, Effectiveness | 合法醫療器材資訊網
2021年2月16日 — BEMER therapy is a relatively new type of pulsed electromagnetic ... to a similar marketed device” that already has FDA clearance or approval. Read More
Class 2 Device Recall Bemer Classic Set | 合法醫療器材資訊網
2021年2月10日 — A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and ... Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
Bemer is marketed as a device that increases blood microcirculation. ... All three persons said that bemer has fda level 1 approval and cannot be used to treat ... Read More
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