The following data is part of a premarket notification filed by Digitimer Ltd. with the FDA for Digitimer Ds7ap Constant Current Stimulator.
| Device ID | K172381 |
| 510k Number | K172381 |
| Device Name: | Digitimer DS7AP Constant Current Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Digitimer Ltd. 37 Hydeway Welwyn Garden City, GB |
| Contact | John Smale |
| Correspondent | John Smale Digitimer Ltd. 37 Hydeway Welwyn Garden City, GB |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-07 |
| Decision Date | 2018-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060490360058 | K172381 | 000 |