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SLENDERTONE CoreFit Abs 8
BIO-MEDICAL RESEARCH LIMITED · Model 734 · UDI-DI 15099058734007
10
510(k) clearances
99
Adverse events
3
Recalls
207
Facilities
Description
The SLENDERTONE CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-13 | BEMER INT. AG | There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker. |
| 2013-05-23 | Pinook-Usa | Failure to submit a premarket submission and gain approval of a medical device. |
| 2013-05-23 | Pinook-Usa | Failure to submit a premarket submission and gain approval of a medical device. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.