# K091727: Medical Treatment Chair,  T400, T500,T600

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care South Asia Pacific Pty, Ltd.
- Decided: Jul 6, 2009 after 25 days
- Product code: INO (Chair, Positioning, Electric)
- Device class: 2
- Regulation: 21 CFR 890.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Convertible© I-Series Positioning and Transfer Chair: named in the summary without a submission number

## Indications for use
The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking blood from, patients in hospital departments or home use. under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use In day surgery and nursing homes. The chairs are designed so that the occupant is accommodated In a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. All models are intended to be used by patients with a weight not exceeding: - 130kg (T100 and T200 series) - 130kg (T300 and T400 series) - 200kg (T500, T550, T600 and T650 series) - 300kg (T500B, T600B)

Source page: https://510kreport.com/device/K091727
Methodology: https://510kreport.com/methodology