The following data is part of a premarket notification filed by Danninger Medical Technology, Inc. with the FDA for Mobilimb Hand Unit.
| Device ID | K844033 |
| 510k Number | K844033 |
| Device Name: | MOBILIMB HAND UNIT |
| Classification | Exerciser, Finger, Powered |
| Applicant | DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Product Code | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-15 |
| Decision Date | 1984-11-27 |