The following data is part of a premarket notification filed by Ames Technology, Inc. with the FDA for Ames Therapy Device.
| Device ID | K123746 |
| 510k Number | K123746 |
| Device Name: | AMES THERAPY DEVICE |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | AMES TECHNOLOGY, INC. 927 THRONE DRIVE Eugene, OR 97402 |
| Contact | Sheila Ramerman, Rac |
| Correspondent | Sheila Ramerman, Rac AMES TECHNOLOGY, INC. 927 THRONE DRIVE Eugene, OR 97402 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-06 |
| Decision Date | 2013-05-24 |
| Summary: | summary |