IKW · Utensil, Homemaking
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | IKW |
|---|---|
| Device Name | Utensil, Homemaking |
| Regulation | 21 CFR 890.5050 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831545 | REACHER & DOOR OPENER | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K823633 | TURNERS FOR KNOBS | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823607 | CARPET SWEEPER | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823605 | PORTABLE ELECTRIC CAN OPENER | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K821646 | TINY FLEX-GLASS, SET OF 4 | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K813631 | JAR HOLDER & OPENER | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K810454 | HOMEMAKING UTENSILS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K790173 | BK-5371 GAD-19-BOUT PERSONAL MOBIL AID | Fred Sammons, Inc. | Feb 22, 1979 | SESE |
| K761124 | WEED PULLER & PRUNER | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
| K761122 | PRUNING SCISSORS | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
| K761115 | ROLLING PIN | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
| K760294 | LEVERS, DOOR KNOB, BK-6395 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 12 clearances
