The following data is part of a premarket notification filed by Alive, Inc. with the FDA for Hakomed Elecdt/vacupulls.
| Device ID | K980958 |
| 510k Number | K980958 |
| Device Name: | HAKOMED ELECDT/VACUPULLS |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ALIVE, INC. 537 CUMMINS ST. Honolulu, HI 96814 |
| Contact | Kai Hansjurgens |
| Correspondent | Kai Hansjurgens ALIVE, INC. 537 CUMMINS ST. Honolulu, HI 96814 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-05-11 |