The following data is part of a premarket notification filed by Rehabtronics Inc. with the FDA for Regrasp.
| Device ID | K153163 |
| 510k Number | K153163 |
| Device Name: | ReGrasp |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Rehabtronics Inc. #4532, 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Contact | Mike Pearson |
| Correspondent | Mike Pearson Rehabtronics Inc. #4532, 10230 Jasper Avenue Edmonton, CA T5j 4p6 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540176030109 | K153163 | 000 |
| 17540176030239 | K153163 | 000 |
| 17540176030222 | K153163 | 000 |
| 17540176030215 | K153163 | 000 |
| 17540176030208 | K153163 | 000 |
| 17540176030192 | K153163 | 000 |
| 17540176030185 | K153163 | 000 |
| 17540176030178 | K153163 | 000 |
| 17540176030161 | K153163 | 000 |
| 17540176030154 | K153163 | 000 |
| 17540176030246 | K153163 | 000 |
| 17540176030253 | K153163 | 000 |
| 17540176030123 | K153163 | 000 |
| 17540176030093 | K153163 | 000 |
| 17540176030086 | K153163 | 000 |
| 17540176030079 | K153163 | 000 |
| 17540176030062 | K153163 | 000 |
| 17540176030055 | K153163 | 000 |
| 17540176030048 | K153163 | 000 |
| 17540176030000 | K153163 | 000 |
| 17540176030116 | K153163 | 000 |
| 17540176030130 | K153163 | 000 |
| 17540176030147 | K153163 | 000 |