The following data is part of a premarket notification filed by Orthocor Medical with the FDA for Orthocor Active Device Orthocor General Use Active Device.
| Device ID | K121702 |
| 510k Number | K121702 |
| Device Name: | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | ORTHOCOR MEDICAL 200 HOMER AVE. Ashland, MA 01721 |
| Contact | David Rothkopf |
| Correspondent | David Rothkopf ORTHOCOR MEDICAL 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-08 |
| Decision Date | 2013-05-06 |
| Summary: | summary |