The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Model Ps-1 Pena Muscle Stimulator.
| Device ID | K980448 |
| 510k Number | K980448 |
| Device Name: | MODEL PS-1 PENA MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Nichole Riek |
| Correspondent | Nichole Riek RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-04-03 |
| Summary: | summary |