The following data is part of a premarket notification filed by Bardon Ent., Inc. with the FDA for Hand Therapy Assost.
| Device ID | K933418 |
| 510k Number | K933418 |
| Device Name: | HAND THERAPY ASSOST |
| Classification | Exerciser, Finger, Powered |
| Applicant | BARDON ENT., INC. 313 ORANGE PLANK RD. Hampton, VA 23669 |
| Contact | Donald E Barthlome |
| Correspondent | Donald E Barthlome BARDON ENT., INC. 313 ORANGE PLANK RD. Hampton, VA 23669 |
| Product Code | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1994-04-28 |