The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Tenscare Ultima Nms/ems.
| Device ID | K023997 |
| 510k Number | K023997 |
| Device Name: | TENSCARE ULTIMA NMS/EMS |
| Classification | Stimulator, Muscle, Powered |
| Applicant | TENSCARE LTD. 76 STOCKPORT ROAD Timperley, Cheshire, GB Wa15 7sn |
| Contact | Bernard J Tremaine |
| Correspondent | Bernard J Tremaine TENSCARE LTD. 76 STOCKPORT ROAD Timperley, Cheshire, GB Wa15 7sn |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-03 |
| Decision Date | 2003-03-03 |
| Summary: | summary |