The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Flex-cup Percussor.
| Device ID | K892862 |
| 510k Number | K892862 |
| Device Name: | FLEX-CUP PERCUSSOR |
| Classification | Percussor, Powered-electric |
| Applicant | LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Contact | Judy Udvare |
| Correspondent | Judy Udvare LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-05-25 |