The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Sensory Roller Massager.
| Device ID | K833090 |
| 510k Number | K833090 |
| Device Name: | SENSORY ROLLER MASSAGER |
| Classification | Massager, Therapeutic, Electric |
| Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-12 |
| Decision Date | 1983-10-14 |