The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Maxems, Models 1000 And 2000.
| Device ID | K091248 |
| 510k Number | K091248 |
| Device Name: | MAXEMS, MODELS 1000 AND 2000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIO PROTECH, INC. 2626 VALLEY VIEW LANE SUITE 4 Dallas, TX 75234 -6274 |
| Contact | Judy Burton |
| Correspondent | Judy Burton BIO PROTECH, INC. 2626 VALLEY VIEW LANE SUITE 4 Dallas, TX 75234 -6274 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-28 |
| Decision Date | 2009-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817325022105 | K091248 | 000 |
| 20817325021665 | K091248 | 000 |
| 20817325020729 | K091248 | 000 |
| 00817325020718 | K091248 | 000 |
| 20817120020085 | K091248 | 000 |
| 20817120020078 | K091248 | 000 |