Definition: A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, A
| Device Type ID | 5226 |
| Device Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| 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 | NGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5226 |
| Device | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product Code | NGX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Muscle Stimulator. |
| CFR Regulation Number | 890.5850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
A-1 ENGINEERING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AD REMTECHNOLOGY SARL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AK BEAUTY ENTERPRISES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BEMER INT. AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-MEDICAL RESEARCH LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BTL INDUSTRIES LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DJ ORTHOPEDICS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FAMIDOC TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FAMIDOC TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIRSTKIND LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIT-PRO KFT LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HIVOX BIOTEK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HOME SKINOVATIONS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERNATIONAL TRADE GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ION MAGNUM LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMARTMISSIMO TECHNOLOGIES PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WELL BRAIN INTERNATIONAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 14 |
Adverse Event Without Identified Device Or Use Problem | 12 |
No Apparent Adverse Event | 1 |
Fire | 1 |
Patient-Device Incompatibility | 1 |
Patient Device Interaction Problem | 1 |
| Total Device Problems | 30 |