K211967 is an FDA 510(k) clearance for the Sensual Massage, Ultra Pure. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Dreambrands, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 9, 2021, 138 days after receiving the submission on June 24, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms..
| 510(k) Number | K211967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2021 |
| Decision Date | November 09, 2021 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NUC - Lubricant, Personal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. |