Definition: General Wellness Product As Detailed In The Guidance For Purposes Of Imports Only: Https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
| Device Type ID | 2865 |
| Device Name | General Wellness Product |
| Physical State | General Wellness Product As Detailed In The Guidance For Purposes Of Imports Only: Https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674. |
| Technical Method | General Wellness Product As Detailed In The Guidance For Purposes Of Imports Only: Https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674. |
| Target Area | General Wellness Product As Detailed In The Guidance For Purposes Of Imports Only: Https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674. |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | PWC |
| GMP Exempt | Yes |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2865 |
| Device | General Wellness Product |
| Product Code | PWC |