The following data is part of a premarket notification filed by Levolon Company, Inc. with the FDA for Thumbshelper Power Ring.
| Device ID | K864870 |
| 510k Number | K864870 |
| Device Name: | THUMBSHELPER POWER RING |
| Classification | Device, Finger-sucking |
| Applicant | LEVOLON COMPANY, INC. 343 PINERIDGE DR. FOREST PARK, GA 30050 |
| Contact | CHARLES R LEVERETTE |
| Correspondent | CHARLES R LEVERETTE LEVOLON COMPANY, INC. 343 PINERIDGE DR. FOREST PARK, GA 30050 |
| Product Code | LQX |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-12 |
| Decision Date | 1987-02-12 |