Combi Self Propelled Shower Commode
K040677 is the FDA 510(k) clearance record for COMBI SELF PROPELLED SHOWER COMMODE, a class I device, cleared for Kjaerulff Rehabilitation A/S on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position”...". FDA records list one 510(k) clearance for Kjaerulff Rehabilitation A/S. As of , FDA records show no recalls naming K040677.
Clearance record
- Decision date
- Received
- (66 days to decision)
- Product code
- IOR Wheelchair, Mechanical
- Regulation
- 21 CFR 890.3850
- Device class
- Class I
- Review panel
- Physical Medicine
- Applicant
- Kjaerulff Rehabilitation A/S Orkebyvej 6, Otterup, DK
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code IOR
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 2 |
| January 2026 | 2 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 2 |
| June 2026 | 4 |
| July 2026 | 1 |
| August 2026 | 1 |
| September 2026 | 5 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
