510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952090Substantially Equivalent

Humac System

Computer Sports Medicine, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952090 is the FDA 510(k) clearance record for HUMAC SYSTEM, a class II device, cleared for Computer Sports Medicine, Inc. on under FDA product code IKK (System, Isokinetic Testing And Evaluation). FDA records list one 510(k) clearance for Computer Sports Medicine, Inc. As of , FDA records show no recalls naming K952090.

Clearance record

Decision date
Received
(222 days to decision)
Product code
IKK System, Isokinetic Testing And Evaluation
Regulation
21 CFR 890.1925
Device class
Class II
Review panel
Physical Medicine
Applicant
Computer Sports Medicine, Inc. 135 Beaver St., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code IKK

Trailing 12 months

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

FDA records show no clearances under product code IKK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKK, 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