The following data is part of a premarket notification filed by Unibell S.r.l with the FDA for Human Tecar Hcr 1002.
| Device ID | K181211 |
| 510k Number | K181211 |
| Device Name: | Human Tecar HCR 1002 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | UNIBELL S.r.l Via Indipendenza, 27 Calco, IT 23885 |
| Contact | Mario Scerri |
| Correspondent | Marisa Testa Thema S.r.l Via Saragat, 5 Imola, IT 40026 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056182721136 | K181211 | 000 |
| 08056182720962 | K181211 | 000 |
| 08056182720955 | K181211 | 000 |
| 08056182720948 | K181211 | 000 |
| 08056182720931 | K181211 | 000 |
| 08056182720924 | K181211 | 000 |
| 08056182720917 | K181211 | 000 |
| 08056182720900 | K181211 | 000 |
| 08056182720894 | K181211 | 000 |
| 08056182720887 | K181211 | 000 |
| 08056182720870 | K181211 | 000 |
| 08056182720863 | K181211 | 000 |
| 08056182720856 | K181211 | 000 |
| 08056182720849 | K181211 | 000 |
| 08056182720832 | K181211 | 000 |
| 08056182720979 | K181211 | 000 |
| 08056182720986 | K181211 | 000 |
| 08056182721129 | K181211 | 000 |
| 08056182721112 | K181211 | 000 |
| 08056182721105 | K181211 | 000 |
| 08056182721099 | K181211 | 000 |
| 08056182721082 | K181211 | 000 |
| 08056182721075 | K181211 | 000 |
| 08056182721068 | K181211 | 000 |
| 08056182721051 | K181211 | 000 |
| 08056182721044 | K181211 | 000 |
| 08056182721037 | K181211 | 000 |
| 08056182721020 | K181211 | 000 |
| 08056182721013 | K181211 | 000 |
| 08056182721006 | K181211 | 000 |
| 08056182720993 | K181211 | 000 |
| 08056182720283 | K181211 | 000 |