The following data is part of a premarket notification filed by Doctors Orders with the FDA for Dvtcare Ca5.
| Device ID | K061125 |
| 510k Number | K061125 |
| Device Name: | DVTCARE CA5 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DOCTORS ORDERS 731 B CONSTRUCTION CT. Zeeland, MI 49464 |
| Contact | Jerry Kulas |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2006-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977445260 | K061125 | 000 |
| 05690977445253 | K061125 | 000 |
| 05690977445246 | K061125 | 000 |
| 05690977371903 | K061125 | 000 |
| 05690977371897 | K061125 | 000 |
| 05690977371866 | K061125 | 000 |