Data / Medical devices / United States / Rael, Inc.
Rael, Inc.: FDA-registered device maker in Buena Park, CA, United States, 5 510(k) clearances
Rael, Inc. is registered with the FDA (registration 3013354376) in Buena Park, CA, United States. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 7, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013354376
- Address
- 6940 Beach Blvd. D-301, Buena Park, CA, United States, 90621
- Owner or operator
- Rael, Inc. (10053897)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 10, 2017
- Registered through
- 2026
- Brand names listed
- Advanced Strength Retinol Spot Cover, Rael Beauty Miracle Patch Invisible Spot Cover, Rael Beauty Miracle Patch Microcrystal Spot Cover, Rael Beauty Miracle Patch Spot Control Cover, Rael Compact Tampon, Rael MIRACLE PATCH DUO Invisible Spot Cover + Spot Control Cover, Rael Menstrual Cup, Rael Micro Thin Organic Cotton Cover Daily Liners - Regular and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2019 | K191431 | Interlude Rolled Tampons in Plastic Applicator | HEB | Substantially Equivalent | Albaad Fem | accessdata.fda.gov |
| July 15, 2019 | K182814 | Rael Tampon | HEB | Substantially Equivalent | Rael, Inc. | accessdata.fda.gov |
| November 2, 2018 | K181911 | Interlude 100% Cotton Tampon | HEB | Substantially Equivalent | Albaad Fem | accessdata.fda.gov |
| December 4, 2015 | K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| November 23, 2004 | K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HIL | Substantially Equivalent | Rostam , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Nursing Pad, Cohesive Gel
- All makers of Garment, Protective, For Incontinence
- All makers of Tampon, Menstrual, Unscented
- All makers of Pad, Menstrual, Unscented
- All makers of Dressing, Wound, Occlusive
- All makers of Tampon, Menstrual, Scented, Scented-Deodorized
Updated October 7, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.