510(k) K923365

TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM by Labsystems, Inc. — Product Code ITI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 24, 1993
Date Received: July 8, 1992
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wheelchair, Powered
Device Class: Class II
Regulation Number: 890.3860
Review Panel: PM
Submission Type

A powered wheelchair is a battery-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 to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Other clearances by Labsystems, Inc.

K896474 — RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (January 25, 1990)
K890154 — MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (February 7, 1989)
K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (February 3, 1989)
K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (April 4, 1988)
K873780 — MODIFICATION RUBELLA IGM EIA TEST KIT (October 15, 1987)
K873583 — AUTO-EIA (September 22, 1987)
K872252 — MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (July 1, 1987)
K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
K862431 — RUBELLA IGM EIA TEST KIT (August 8, 1986)
K862216 — TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (June 30, 1986)

Other clearances for product code ITI

K253870 — Electric Wheelchair (MP148) (March 4, 2026)
K253789 — Electric wheelchair (February 25, 2026)
K253707 — Electric wheelchair (W1,W3) (February 24, 2026)
K253599 — Electric Wheelchair (W-A807, W-A807L) (February 17, 2026)
K253276 — Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E (January 15, 2026)
K251458 — Electric Wheelchair (DH01168) (January 15, 2026)
K251159 — Power wheelchair (December 22, 2025)
K252862 — Electric Wheelchair (DH01126) (December 8, 2025)
K252494 — Electrically powered wheelchair (KZ301B) (December 5, 2025)
K252829 — Powered Wheelchair (PL001-9001) (November 12, 2025)