| Device Type ID | 3684 |
| Device Name | Stimulator, Neuromuscular, External Functional |
| Regulation Description | External Functional Neuromuscular Stimulator. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| 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 | 882.5810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZI |
| 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 | 3684 |
| Device | Stimulator, Neuromuscular, External Functional |
| Product Code | GZI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Functional Neuromuscular Stimulator. |
| CFR Regulation Number | 882.5810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIONESS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIONESS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HASOMED GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INNOVATIVE NEUROTRONICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MYNDTEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MYOLYN, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ODSTOCK MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OTTO BOCK HEALTHCARE GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OTTO BOCK HEALTHCARE, GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN XFT MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TECHLINK INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Impedance | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |