DeviceClearance

GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM— 510(k) K071050

Substantially Equivalent

Coolsystems, Inc.

FDA 510(k) clearance K071050 for GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM, Substantially Equivalent on 2007-06-29. Applicant: Coolsystems, Inc.. Device class: 2.

Clearance details

Applicant
Coolsystems, Inc.
Product code
Code IRP
Device class
Class 2
Regulation
21 CFR 890.5650
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Berkeley, CA, US
Download summary PDFView on FDA.gov ↗

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