The following data is part of a premarket notification filed by Ormed Gmbh with the FDA for Artrotherm Cryotherapy And Thernotherapy.
| Device ID | K964799 |
| 510k Number | K964799 |
| Device Name: | ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | ORMED GMBH 1000 BURNETTE AVE., SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf ORMED GMBH 1000 BURNETTE AVE., SUITE 450 Concord, CA 94520 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-08-29 |
| Summary: | summary |