IKX · Aid, Transfer
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | IKX |
|---|---|
| Device Name | Aid, Transfer |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K862895 | TRICYCLES | Mednet, Inc. | Aug 13, 1986 | SESE |
| K842650 | WALL GRAB BARS 98130-98136 | Guardian Products Co., Inc. | Aug 10, 1984 | SESE |
| K831541 | TUB TRANSFER BENCH BK6481 | Fred Sammons, Inc. | Jun 2, 1983 | SESE |
| K823640 | BATH TUB SAFETY BAR | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823639 | BOARD TO TRANSFER PARALYZED PATIENT FROM | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823634 | CHAIR OR BED LEG EXTENDERS | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823154 | SHOWER STOOL W/HANDLES | Orthion Corp. | Nov 5, 1982 | SESE |
| K823153 | BATH TUB SEAT & BATH BOARD | Orthion Corp. | Nov 5, 1982 | SESE |
| K821903 | DISC-O-AID | M. Dahm International Aps | Jul 20, 1982 | SESE |
| K821010 | BATHTUB TRANSFER BENCH | Guardian Products Co., Inc. | Apr 21, 1982 | SESE |
| K813629 | BK-6111 HI-D TRANSFER BOARD | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K812475 | TRANSFER BENCH | Maddak, Inc. | Sep 14, 1981 | SESE |
| K810449 | TRANSFER AIDS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K810275 | GRAB BARS | Maddak, Inc. | Feb 12, 1981 | SESE |
| K792247 | TAYLOR PATIENT TRANSFER BOARD | Taylor Medical Equipment | Nov 30, 1979 | SESE |
| K781201 | BOARD, TRANSFER, FENDER | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K780935 | GRAB BAR | Orthopedic Equipment Co., Inc. | Jun 19, 1978 | SESE |
| K772417 | SLIDING BOARD | Fred Sammons, Inc. | Jan 5, 1978 | SESE |
Top Applicants
- Fred Sammons, Inc. — 8 clearances
- Guardian Products Co., Inc. — 2 clearances
- Maddak, Inc. — 2 clearances
- Orthion Corp. — 2 clearances
- M. Dahm International Aps — 1 clearance
