The following data is part of a premarket notification filed by Regenesis Biomedical, Inc. with the FDA for Provant System, Model 4201.
| Device ID | K091791 |
| 510k Number | K091791 |
| Device Name: | PROVANT SYSTEM, MODEL 4201 |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | REGENESIS BIOMEDICAL, INC. 1435 NORTH HAYDEN RD. Scottsdale, AZ 85257 -3773 |
| Contact | Richard Isenberg |
| Correspondent | Richard Isenberg REGENESIS BIOMEDICAL, INC. 1435 NORTH HAYDEN RD. Scottsdale, AZ 85257 -3773 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2010-04-07 |
| Summary: | summary |