The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Ness H200 Wireless Hand Rehabilitation System User Kit And Clinican Kit.
| Device ID | K111767 |
| 510k Number | K111767 |
| Device Name: | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 19 HA'HAROSHET ST. Ra'anana, IL 43654 |
| Contact | Monica Stachura,jd |
| Correspondent | Monica Stachura,jd NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 19 HA'HAROSHET ST. Ra'anana, IL 43654 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-23 |
| Decision Date | 2011-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815962020290 | K111767 | 000 |
| 00810188050366 | K111767 | 000 |
| 00810188050373 | K111767 | 000 |
| 00810188050380 | K111767 | 000 |
| 00810188050397 | K111767 | 000 |
| 00810188050403 | K111767 | 000 |
| 00810188050410 | K111767 | 000 |
| 00810188050427 | K111767 | 000 |
| 00810188050434 | K111767 | 000 |
| 00810188050601 | K111767 | 000 |
| 00810188050359 | K111767 | 000 |