The following data is part of a premarket notification filed by Neotonus, Inc. with the FDA for Neotonus Ms-101 Magnetic Muscle Stimulator System.
| Device ID | K973929 |
| 510k Number | K973929 |
| Device Name: | NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | James R Veale |
| Correspondent | James R Veale NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1998-05-21 |
| Summary: | summary |