The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Well Life Self Adhesive Electrode / Models: Cm, Fa, Pu And Sp.
| Device ID | K082065 |
| 510k Number | K082065 |
| Device Name: | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP |
| Classification | Electrode, Cutaneous |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 24301 WOODSAGE DR Bontia Spring, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden WELL-LIFE HEALTHCARE LIMITED 24301 WOODSAGE DR Bontia Spring, FL 34134 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-22 |
| Decision Date | 2009-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20050428520066 | K082065 | 000 |
| B311PEPROBELT0 | K082065 | 000 |
| B311PEPROPAD0 | K082065 | 000 |
| 04719872260028 | K082065 | 000 |
| 04719872260073 | K082065 | 000 |
| 00853635002051 | K082065 | 000 |
| 00853635002112 | K082065 | 000 |
| 00853635002266 | K082065 | 000 |
| 00853635002273 | K082065 | 000 |
| 00853635002280 | K082065 | 000 |
| 20853635002451 | K082065 | 000 |
| 10853635002461 | K082065 | 000 |
| 00856675008205 | K082065 | 000 |
| 00856675008212 | K082065 | 000 |
| 00856675008236 | K082065 | 000 |
| 10856675008257 | K082065 | 000 |
| 10856675008264 | K082065 | 000 |
| 20856675008278 | K082065 | 000 |
| B311PEPADBFLY1 | K082065 | 000 |