510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022652Substantially Equivalent

Alphatrac, Model a 205

Teftec Corp., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022652 is the FDA 510(k) clearance record for ALPHATRAC, MODEL A 205, a class II device, cleared for Teftec Corp. on under FDA product code ITI (Wheelchair, Powered). FDA's definition for product code ITI reads: "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...". FDA records list 8 510(k) clearances for Teftec Corp., from to . As of , FDA records show no recalls naming K022652.

Clearance record

Decision date
Received
(104 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
Device class
Class II
Review panel
Physical Medicine
Applicant
Teftec Corp. 12450 Network Blvd., San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITI

Trailing 12 months
36 clearances under product code ITI in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code ITI, trailing twelve months
MonthClearances
November 20253
December 20253
January 20262
February 20263
March 20267
April 20263
May 20261
June 20266
July 20263
August 20261
September 20264
October 20260