The following data is part of a premarket notification filed by Weaver Medical Electronics, Inc. with the FDA for W.m.e. Gps 1001.
| Device ID | K961751 |
| 510k Number | K961751 |
| Device Name: | W.M.E. GPS 1001 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | WEAVER MEDICAL ELECTRONICS, INC. 145 VIVIAN ST. Longmont, CO 80501 |
| Contact | Benson C Weaver |
| Correspondent | Benson C Weaver WEAVER MEDICAL ELECTRONICS, INC. 145 VIVIAN ST. Longmont, CO 80501 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1997-09-25 |