| Device Type ID | 5171 |
| Device Name | Massager, Therapeutic, Electric |
| Regulation Description | Therapeutic Massager. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ISA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5171 |
| Device | Massager, Therapeutic, Electric |
| Product Code | ISA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Therapeutic Massager. |
| CFR Regulation Number | 890.5660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STORZ | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STORZ MEDICAL AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Use Of Device Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Emits Odor | 1 |
Thermal Decomposition Of Device | 1 |
Overheating Of Device | 1 |
| Total Device Problems | 9 |