The following data is part of a premarket notification filed by Odstock Medical Ltd with the FDA for Odfs Pace Xl.
| Device ID | K171396 |
| 510k Number | K171396 |
| Device Name: | ODFS Pace XL |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Odstock Medical Ltd Salisbury District Hospital Salisbury, GB Sp2 8bj |
| Contact | Steven Crook |
| Correspondent | Steven Crook Odstock Medical Ltd Salisbury District Hospital Salisbury, GB Sp2 8bj |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-11 |
| Decision Date | 2018-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060195470441 | K171396 | 000 |