IKX
18 FDA 510(k) clearances · Product code
21 daysmedian time to decision
46 days90th percentile
18clearances measured
FDA profile
- Official device name
- Aid, Transfer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2016: 17 · 2017: 16 · 2018: 15 · 2019: 15 · 2020: 11 · 2022: 50
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TRICYCLES (K862895) | Mednet, Inc. | 1986-08-13 |
| WALL GRAB BARS 98130-98136 (K842650) | Guardian Products Co., Inc. | 1984-08-10 |
| TUB TRANSFER BENCH BK6481 (K831541) | Fred Sammons, Inc. | 1983-06-02 |
| BATH TUB SAFETY BAR (K823640) | Fred Sammons, Inc. | 1983-01-21 |
| BOARD TO TRANSFER PARALYZED PATIENT FROM (K823639) | Fred Sammons, Inc. | 1983-01-21 |
| CHAIR OR BED LEG EXTENDERS (K823634) | Fred Sammons, Inc. | 1982-12-28 |
| BATH TUB SEAT & BATH BOARD (K823153) | Orthion Corp. | 1982-11-05 |
| SHOWER STOOL W/HANDLES (K823154) | Orthion Corp. | 1982-11-05 |
| DISC-O-AID (K821903) | M. Dahm International Aps | 1982-07-20 |
| BATHTUB TRANSFER BENCH (K821010) | Guardian Products Co., Inc. | 1982-04-21 |
| BK-6111 HI-D TRANSFER BOARD (K813629) | Fred Sammons, Inc. | 1982-01-19 |
| TRANSFER BENCH (K812475) | Maddak, Inc. | 1981-09-14 |
| TRANSFER AIDS (K810449) | Fred Sammons, Inc. | 1981-03-04 |
| GRAB BARS (K810275) | Maddak, Inc. | 1981-02-12 |
| TAYLOR PATIENT TRANSFER BOARD (K792247) | Taylor Medical Equipment | 1979-11-30 |
| BOARD, TRANSFER, FENDER (K781201) | Fred Sammons, Inc. | 1978-07-31 |
| GRAB BAR (K780935) | Orthopedic Equipment Co., Inc. | 1978-06-19 |
| SLIDING BOARD (K772417) | Fred Sammons, Inc. | 1978-01-05 |
Track IKX automatically
Every clearance here is in the API, with alerts when new ones post.