The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Modification To Handmaster.
| Device ID | K012823 |
| 510k Number | K012823 |
| Device Name: | MODIFICATION TO HANDMASTER |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Hahan |
| Correspondent | Jonathan S Hahan NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 555 13TH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-11-14 |
| Summary: | summary |