The following data is part of a premarket notification filed by Bt Medical Co., Inc. with the FDA for Btm-200 (proposed) Powered Muscle Stimulator.
| Device ID | K915321 |
| 510k Number | K915321 |
| Device Name: | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR |
| 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 | 1991-11-22 |
| Decision Date | 1992-07-17 |