The following data is part of a premarket notification filed by Bt Medical Co., Inc. with the FDA for Btm-100 Powered Muscle Stimulator (proposed).
| Device ID | K914999 |
| 510k Number | K914999 |
| Device Name: | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BT MEDICAL CO., INC. C/O MALLOY, NOBLITT & RUELAND 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92714 |
| Contact | John J Malloy |
| Correspondent | John J Malloy BT MEDICAL CO., INC. C/O MALLOY, NOBLITT & RUELAND 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92714 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-07 |
| Decision Date | 1992-04-23 |