The following data is part of a premarket notification filed by Heelbo, Inc. with the FDA for Great Hands Mitts.
| Device ID | K962810 |
| 510k Number | K962810 |
| Device Name: | GREAT HANDS MITTS |
| Classification | Restraint, Protective |
| Applicant | HEELBO, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HEELBO, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-09 |
| Summary: | summary |