The following data is part of a premarket notification filed by Competitive Technologies,inc. with the FDA for Scrambler St 5 Tens Device.
| Device ID | K081255 |
| 510k Number | K081255 |
| Device Name: | SCRAMBLER ST 5 TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | COMPETITIVE TECHNOLOGIES,INC. 49 PLAIN ST. North Attleboro, MA 02760 -2 |
| Contact | Mary Mcnamara |
| Correspondent | Mary Mcnamara COMPETITIVE TECHNOLOGIES,INC. 49 PLAIN ST. North Attleboro, MA 02760 -2 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2009-02-20 |
| Summary: | summary |