Dry Comfort Undergarment
FDA 510(k) K882418 · Health Tec, Inc.
510(k) numberK882418
Submission
- Device name
- Dry Comfort Undergarment
- Applicant
- Health Tec, Inc.
Palmer, MA, US - Received
- June 13, 1988
- Decision date
- September 29, 1988
- 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
Other 510(k)s with product code EYQ
| 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 |
| K880454 | At Ease Stress PadEYQ · Traditional | Hospital Specialty Co. | 06/16/1988SE |
| K880455 | At Ease Adult DiaperEYQ · Traditional | Hospital Specialty Co. | 04/14/1988SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K881969 | Dry Comfort Disposable UnderpadKME · Traditional | 06/07/1988SE |
Questions and answers
When was Dry Comfort Undergarment cleared by the FDA?
Dry Comfort Undergarment (K882418) received a 510(k) decision of Substantially Equivalent on September 29, 1988, 108 days after the submission was received.
What is the product code of K882418?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.