| Device Type ID | 5173 |
| Device Name | Exerciser, Measuring |
| Regulation Description | Measuring 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 | 890.5360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ISD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5173 |
| Device | Exerciser, Measuring |
| Product Code | ISD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Measuring Exercise Equipment. |
| CFR Regulation Number | 890.5360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PENUMBRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SLEEP MODUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
None | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BTE Technologies, Inc. | II | Jul-06-2015 |
| 2 | MedX Holdings, Inc. | II | Jan-07-2015 |