The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Electro-mesh Sock, Wrap, And Sleeve Electrodes.
| Device ID | K944487 |
| 510k Number | K944487 |
| Device Name: | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | PRIZM MEDICAL, INC. 3050 BUSINESS PARK DR. SUITE A2 Norcross, GA 30071 |
| Contact | James P Johnson |
| Correspondent | James P Johnson PRIZM MEDICAL, INC. 3050 BUSINESS PARK DR. SUITE A2 Norcross, GA 30071 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1995-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B872SSS23050 | K944487 | 000 |
| B872SSELBW0 | K944487 | 000 |
| B872SSKNEE0 | K944487 | 000 |
| B872SSNECK0 | K944487 | 000 |
| B872SSSHLD0 | K944487 | 000 |
| B872EMG20130 | K944487 | 000 |
| B872EMSP240 | K944487 | 000 |
| B872EMSP440 | K944487 | 000 |
| B872EMSP480 | K944487 | 000 |
| B872STS33130 | K944487 | 000 |
| B872STS33140 | K944487 | 000 |
| B872STS33150 | K944487 | 000 |
| B872EMG20140 | K944487 | 000 |
| B872EMG20150 | K944487 | 000 |
| B872ITBK440 | K944487 | 000 |