The following data is part of a premarket notification filed by Regenesis Biomedical, Inc. with the FDA for Provant Therapy System.
| Device ID | K131979 |
| 510k Number | K131979 |
| Device Name: | PROVANT THERAPY SYSTEM |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | REGENESIS BIOMEDICAL, INC. 5301 NORTH PIMA ROAD SUITE 150 Scottsdale, AZ 85250 -3773 |
| Contact | Richard Isenberg |
| Correspondent | Richard Isenberg REGENESIS BIOMEDICAL, INC. 5301 NORTH PIMA ROAD SUITE 150 Scottsdale, AZ 85250 -3773 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2013-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868924000021 | K131979 | 000 |