The following data is part of a premarket notification filed by Rochester Electro Medical, Inc. with the FDA for Disposable Pre-gelled Surface Electrode.
| Device ID | K142159 |
| 510k Number | K142159 |
| Device Name: | DISPOSABLE PRE-GELLED SURFACE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | ROCHESTER ELECTRO MEDICAL, INC. 19404 PINE VALLEY DRIVE Odessa, FL 33556 |
| Contact | Wayne Glover |
| Correspondent | Wayne Glover ROCHESTER ELECTRO MEDICAL, INC. 19404 PINE VALLEY DRIVE Odessa, FL 33556 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2015-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849593015554 | K142159 | 000 |
| 00849593015899 | K142159 | 000 |
| 00849593015882 | K142159 | 000 |
| 00849593015448 | K142159 | 000 |
| 00849593015431 | K142159 | 000 |
| 00849593015424 | K142159 | 000 |
| 00849593015400 | K142159 | 000 |
| 00849593009393 | K142159 | 000 |
| 00849593009386 | K142159 | 000 |
| 00849593015486 | K142159 | 000 |
| 00849593015332 | K142159 | 000 |
| 00849593016681 | K142159 | 000 |
| 00849593015745 | K142159 | 000 |
| 00849593015721 | K142159 | 000 |
| 00849593015356 | K142159 | 000 |
| 00849593015905 | K142159 | 000 |
| 00849593015929 | K142159 | 000 |
| 00849593015936 | K142159 | 000 |
| 00849593009195 | K142159 | 000 |
| 00849593015769 | K142159 | 000 |
| 00849593015493 | K142159 | 000 |
| 00849593009362 | K142159 | 000 |
| 00849593009331 | K142159 | 000 |
| 00849593009324 | K142159 | 000 |
| 00849593009317 | K142159 | 000 |
| 00849593009300 | K142159 | 000 |
| 00849593009294 | K142159 | 000 |
| 00849593009263 | K142159 | 000 |
| 00849593009188 | K142159 | 000 |
| 00849593015998 | K142159 | 000 |
| 00849593015981 | K142159 | 000 |
| 00849593015950 | K142159 | 000 |
| 00849593015349 | K142159 | 000 |