The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Prostim 1000/2000.
| Device ID | K073438 |
| 510k Number | K073438 |
| Device Name: | PROSTIM 1000/2000 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-07 |
| Decision Date | 2008-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817325020701 | K073438 | 000 |
| 20817325020699 | K073438 | 000 |
| 20817120020566 | K073438 | 000 |
| 00817120020036 | K073438 | 000 |
| 00817120020029 | K073438 | 000 |
| 00815290016385 | K073438 | 000 |
| 00857771003989 | K073438 | 000 |
| M220P6420003 | K073438 | 000 |
| 00749756363419 | K073438 | 000 |