TRICYCLES
FDA 510(k) clearance K862895 · decided 1986-08-13
Clearance details
- K-number
- K862895
- Device name
- TRICYCLES
- Applicant
- Mednet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-22
- Decision date
- 1986-08-13
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- IKX
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Battle Creek, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.