Utensil, Homemaking
Homemaking Utensils are adapted household tools used in Physical Medicine and occupational therapy to assist patients with limited hand function or mobility in performing daily living tasks such as cooking, cleaning, and household management. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IKW, regulated under 21 CFR 890.5050, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
Basic Information
- Product Code
- IKW
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831545 | REACHER & DOOR OPENER | Jun 08, 1983 | Substantially Equivalent | FRED SAMMONS, INC. |
| K823633 | TURNERS FOR KNOBS | Dec 28, 1982 | Substantially Equivalent | FRED SAMMONS, INC. |
| K823607 | CARPET SWEEPER | Dec 28, 1982 | Substantially Equivalent | FRED SAMMONS, INC. |
| K823605 | PORTABLE ELECTRIC CAN OPENER | Dec 28, 1982 | Substantially Equivalent | FRED SAMMONS, INC. |
| K821646 | TINY FLEX-GLASS, SET OF 4 | Jun 11, 1982 | Substantially Equivalent | FRED SAMMONS, INC. |
| K813631 | JAR HOLDER & OPENER | Jan 19, 1982 | Substantially Equivalent | FRED SAMMONS, INC. |
| K810454 | HOMEMAKING UTENSILS | Mar 04, 1981 | Substantially Equivalent | FRED SAMMONS, INC. |
| K790173 | BK-5371 GAD-19-BOUT PERSONAL MOBIL AID | Feb 22, 1979 | Substantially Equivalent | FRED SAMMONS, INC. |
| K761124 | WEED PULLER & PRUNER | Dec 02, 1976 | Substantially Equivalent | FRED SAMMONS, INC. |
| K761122 | PRUNING SCISSORS | Dec 02, 1976 | Substantially Equivalent | FRED SAMMONS, INC. |
| K761115 | ROLLING PIN | Dec 02, 1976 | Substantially Equivalent | FRED SAMMONS, INC. |
| K760294 | LEVERS, DOOR KNOB, BK-6395 | Sep 08, 1976 | Substantially Equivalent | FRED SAMMONS, INC. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.