The following data is part of a premarket notification filed by Scottcare with the FDA for Telerehad 2004.
| Device ID | K050778 |
| 510k Number | K050778 |
| Device Name: | TELEREHAD 2004 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | SCOTTCARE 4791 WEST 150TH ST. Cleveland, OH 44135 |
| Contact | Wayne Stripe |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2005-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856298006305 | K050778 | 000 |
| 00856298006060 | K050778 | 000 |
| 00856298006077 | K050778 | 000 |
| 00856298006084 | K050778 | 000 |
| 00856298006244 | K050778 | 000 |
| 00856298006251 | K050778 | 000 |
| 00856298006275 | K050778 | 000 |
| 00856298006282 | K050778 | 000 |
| 00856298006299 | K050778 | 000 |
| 00856298006053 | K050778 | 000 |