| Device Type ID | 5130 |
| Device Name | Exerciser, Non-measuring |
| Regulation Description | Nonmeasuring Exercise Equipment. |
| 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 | 890.5370 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ION |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5130 |
| Device | Exerciser, Non-measuring |
| Product Code | ION |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonmeasuring Exercise Equipment. |
| CFR Regulation Number | 890.5370 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 4 |
Product Quality Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Rupture | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amtryke LLC | II | Apr-24-2015 |