The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Hmb-200.
| Device ID | K800250 |
| 510k Number | K800250 |
| Device Name: | HMB-200 |
| Classification | Vibrator, Therapeutic |
| Applicant | ASSOCIATED MILLS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-06 |
| Decision Date | 1980-03-25 |