Ultra Shield Briefs
FDA 510(k) K841953 · Ipco Corp.
510(k) numberK841953
Submission
- Device name
- Ultra Shield Briefs
- Applicant
- Ipco Corp.
Mchenry, IL, US - Received
- May 14, 1984
- Decision date
- July 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYQ – Garment, Protective, For Incontinence
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5920
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950784 | Dristar Urinary Incontinence Management SystemEYQ · Traditional | Advanced Bioresearch Assoc. | 05/03/1995SE |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | Kit Pak, Inc. | 06/01/1994SEKD |
| K903342 | Deodorizing and Sound Muffling Anal PadEYQ · Traditional | Biological Resistance, Inc. | 10/23/1990SE |
| K891686 | Lib System, Baby/Adult DiaperEYQ · Traditional | Intera Corp. | 05/31/1989SE |
| K885185 | Intera Shield and Intera UndergarmentEYQ · Traditional | Intera Corp. | 02/08/1989SE |
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883787 | Reusable Adult Incontinent DiaperEYQ · Traditional | Intera Corp. | 11/07/1988SE |
| K882418 | Dry Comfort UndergarmentEYQ · Traditional | Health Tec, Inc. | 09/29/1988SE |
| K880454 | At Ease Stress PadEYQ · Traditional | Hospital Specialty Co. | 06/16/1988SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K871270 | Perform Denture Base ResinEBF · Traditional | 05/29/1987SE |
| K850666 | Strobex Ultron Electrosurge-Dental UnitEKZ · Traditional | 05/29/1985SE |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | 04/12/1985SE |
| K842837 | Safe & Soft Maxi ShiledsHHD · Traditional | 10/15/1984SE |
| K842836 | Safe & Soft Mini Pads & Maxi PadsHHD · Traditional | 10/15/1984SE |
| K842838 | Safe & Soft Panty ShieldsHHD · Traditional | 10/05/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | 04/13/1984SE |
| K840753 | Ambeze Disposable Incontinence PantsEYQ · Traditional | 04/13/1984SE |
| K800293 | File, Pulp CanalEKS · Traditional | 02/19/1980SE |
Questions and answers
When was Ultra Shield Briefs cleared by the FDA?
Ultra Shield Briefs (K841953) received a 510(k) decision of Substantially Equivalent on July 19, 1984, 66 days after the submission was received.
What is the product code of K841953?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.