The following data is part of a premarket notification filed by Odstock Medical Ltd with the FDA for Odfs Pace.
| Device ID | K102115 |
| 510k Number | K102115 |
| Device Name: | ODFS PACE |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | ODSTOCK MEDICAL LTD SALISBURY DISTRICT HOSPITAL Salisbury, Wiltshire, GB Sp2 8bj |
| Contact | Steven Crook |
| Correspondent | Steven Crook ODSTOCK MEDICAL LTD SALISBURY DISTRICT HOSPITAL Salisbury, Wiltshire, 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 | 2010-07-28 |
| Decision Date | 2011-03-30 |
| Summary: | summary |