The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Am-100.
| Device ID | K163165 |
| 510k Number | K163165 |
| Device Name: | AM-100 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
| Contact | David Chmel |
| Correspondent | David Chmel BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AM-100 73240458 1228912 Dead/Cancelled |
Alpha Microsystems 1979-11-26 |
![]() AM-100 73240418 1228925 Dead/Cancelled |
Alpha Microsystems 1979-11-26 |