uroval.comUROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
UROVAL
UROVAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008361680 | 3008361680 | UROVAL INC/FOLKERTS | 1 | N | 2026-01-01 | 1220 Marlatt Ave Manhattan KS US 66502 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00852523007062 | Uroval - The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity. | 785-539-1787 | info@uroval.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 116029 | 1937359498 | K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | IKN | 2009-09-11 |
| 116029 | 1151894805 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IKN | 1 | 2009-09-11 |
PMN#
GUDID#
Uroval - 6' Electrode Lead Wire Set for use with the Uroval BRS System.
2018-09-27
Uroval - The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.
2018-09-27