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1byone
1BYONEPRODUCTS INC. · Model PL-029K16B-P3 · UDI-DI 00858069007085
10
510(k) clearances
99
Adverse events
3
Recalls
209
Facilities
Description
Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces)
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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