510(k) Report

FDA applicant

Computer Sports Medicine, Inc.

Waltham, MA1 decision1995–19950 recalls

FDA records 1 decision for Computer Sports Medicine, Inc. (Waltham, MA) in 1995: 1 510(k) clearance. All are in product code IKK (System, Isokinetic Testing And Evaluation). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Computer Sports Medicine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Computer Sports Medicine, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Computer Sports Medicine, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Computer Sports Medicine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Computer”

FDA records each applicant name separately; these may or may not be the same firm.