The following data is part of a premarket notification filed by Rehabilicare, Inc. with the FDA for Smp-plus,sx-plus,sx Model # 49xx Series 9 Volt Tens Device.
| Device ID | K982410 |
| 510k Number | K982410 |
| Device Name: | SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Contact | Edward F Valdez |
| Correspondent | Edward F Valdez REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-11-06 |
| Summary: | summary |