FDA Inspection
Zynex Medical, IncZynex Medical, Inc – FDA Inspection, Jul 22, 2026
Record Details
This FDA Inspection record concerns Zynex Medical, Inc, with an inspection on July 22, 2026, issued by the Denver District Office, covering medical devices & rad health.
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ID · 29347dba-80a4-4a26-9d7b-4d40b9256db3
Inspection Facts
- Inspection number
- 1327500
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 806.10(a)(1)Report of risk to health
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.1Non-fulfilment of purchasing requirements not addressed with supplier
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of Zynex Medical, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zynex Medical, Inc
- FDA Inspection 1171956 - 2022-06-15
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