| Device Type ID | 5135 |
| Device Name | Stimulator, Muscle, Powered |
| Regulation Description | Powered Muscle Stimulator. |
| 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) |
| CFR Regulation Number | 890.5850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IPF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5135 |
| Device | Stimulator, Muscle, Powered |
| Product Code | IPF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Muscle Stimulator. |
| CFR Regulation Number | 890.5850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CYMEDICA ORTHOPEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIGITIMER LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DJ ORTHOPEDICS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ELITE MEDICAL SUPPLY OF NEW YORK, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EMSI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIRSTKIND LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
FIRSTKIND LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IBRAMED EQUIPAMENTOS MEDICOS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIVEUS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESTORATIVE THERAPIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMARTMISSIMO TECHNOLOGIES PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Temperature Problem | 10 |
Charred | 9 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Connection Problem | 1 |
Use Of Device Problem | 1 |
Insufficient Information | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zynex Medical, Inc. | II | Jun-26-2014 |