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SUDOSCAN
IMPETO MEDICAL · Model Hand electrode · UDI-DI 03770025753034
10
510(k) clearances
30
Adverse events (2 deaths)
3
Recalls
27
Facilities
Description
Standard electrode hand
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-02 | Hudson Scientific LLC | The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding elect |
| 2015-11-23 | ZYTO Technologies, Inc. | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. |
| 2015-11-23 | ZYTO Technologies, Inc. | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. |
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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.