The following data is part of a premarket notification filed by Premier Sundries, Inc. with the FDA for Visa-grip.
| Device ID | K790191 | 
| 510k Number | K790191 | 
| Device Name: | VISA-GRIP | 
| Classification | Exerciser, Non-measuring | 
| Applicant | PREMIER SUNDRIES, INC. MD | 
| Product Code | ION | 
| CFR Regulation Number | 890.5370 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1979-01-26 | 
| Decision Date | 1979-02-08 |