The following data is part of a premarket notification filed by Ad Rem Technology Sarl with the FDA for Veinoplus Sport Neuromuscular Stimulator.
| Device ID | K141919 |
| 510k Number | K141919 |
| Device Name: | VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | AD REM TECHNOLOGY SARL 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin AD REM TECHNOLOGY SARL 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2015-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701084900039 | K141919 | 000 |
| 03701084900008 | K141919 | 000 |