PELLEFIRM
Massager, Vacuum, Radio Frequency Induced Heat
ELLMAN INTERNATIONAL, INC.
The following data is part of a premarket notification filed by Ellman International, Inc. with the FDA for Pellefirm.
Pre-market Notification Details
| Device ID | K132949 |
| 510k Number | K132949 |
| Device Name: | PELLEFIRM |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | ELLMAN INTERNATIONAL, INC. 400 KARIN LANE Hicksville, NY 11801 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe ELLMAN INTERNATIONAL, INC. 400 KARIN LANE Hicksville, NY 11801 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-19 |
| Decision Date | 2014-02-20 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108250 | K132949 | 000 |
| 00841494108243 | K132949 | 000 |
| 00841494108236 | K132949 | 000 |
| 00841494108229 | K132949 | 000 |
| 00841494108212 | K132949 | 000 |
| 00841494105297 | K132949 | 000 |
| 00841494105280 | K132949 | 000 |
| 00841494105112 | K132949 | 000 |
Trademark Results [PELLEFIRM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PELLEFIRM 86129907 4590385 Live/Registered |
CYNOSURE, LLC 2013-11-26 |
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