Primary Device ID | 17540176030116 |
NIH Device Record Key | 0a8fcefc-64ef-48c4-be9e-eb83da784cac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ReGrasp |
Version Model Number | RHTHS1B |
Company DUNS | 243936569 |
Company Name | Rehabtronics Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 17540176030116 [Primary] |
GZI | Stimulator, Neuromuscular, External Functional |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2019-09-17 |
17540176030109 | ReGrasp Replacement Wrist-Support |
17540176030093 | ReGrasp Clinician System Refill |
17540176030086 | ReGrasp Clinician System |
17540176030079 | ReGrasp Electrode Set |
17540176030062 | ReGrasp Replacement Garment (Large Size) |
17540176030055 | ReGrasp Replacement Garment (Medium Size) |
17540176030048 | ReGrasp Replacement Garment (Small Size) |
17540176030000 | ReGrasp Personal System |
17540176030116 | ReGrasp Base System |
17540176030130 | ReGrasp Electrode Positioning Kit Refill |
17540176030123 | ReGrasp Electrode Positioning Kit |
17540176030253 | EPKV2 Dock Assembly |
17540176030246 | EPK Cotton Electrodes (Small) |
17540176030239 | EPK Cotton Electrodes (Large) |
17540176030222 | EPK Small Gel Electrodes |
17540176030215 | EPK Large Gel Electrodes |
17540176030208 | EPK Pens |
17540176030192 | EPK Transfer Sheet |
17540176030185 | ReGrasp Garment Liners (large) |
17540176030178 | ReGrasp Garment Liners (medium) |
17540176030161 | ReGrasp Garment Liners (small) |
17540176030154 | ReGrasp HMS Button Control |
17540176030147 | ReGrasp Electrode Positioning Kit Version 2 |