510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191334Substantially Equivalent

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08

Matia Robotics (US), Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191334 is the FDA 510(k) clearance record for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08, a class II device, cleared for Matia Robotics (Us), Inc. on under FDA product code IPL (Wheelchair, Standup). FDA records list one 510(k) clearance for Matia Robotics (Us), Inc. As of , FDA records show no recalls naming K191334.

Clearance record

Decision date
Received
(378 days to decision)
Product code
IPL Wheelchair, Standup
Regulation
21 CFR 890.3900
Device class
Class II
Review panel
Physical Medicine
Applicant
Matia Robotics (Us), Inc. 1929 S 4130 W, Unit A, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code IPL

Trailing 12 months

FDA records hold no clearances under product code IPL in the trailing twelve months.

FDA records show no clearances under product code IPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260