The following data is part of a premarket notification filed by Bio-tech Co. with the FDA for Consti-ssage Vibrator/massage.
| Device ID | K900674 |
| 510k Number | K900674 |
| Device Name: | CONSTI-SSAGE VIBRATOR/MASSAGE |
| Classification | Massager, Therapeutic, Electric |
| Applicant | BIO-TECH CO. BOX 121 RT 3 Washington, IA 52353 |
| Contact | Victor J Wedel |
| Correspondent | Victor J Wedel BIO-TECH CO. BOX 121 RT 3 Washington, IA 52353 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-03-02 |