Submission Details
| 510(k) Number | K952090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1995 |
| Decision Date | December 11, 1995 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
HUMAC SYSTEM
Dec 1995
Decision
222d
Days
Class 2
Risk
About This 510(k) Submission
K952090 is an FDA 510(k) clearance for the HUMAC SYSTEM, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Computer Sports Medicine, Inc. (Waltham, US). The FDA issued a Cleared decision on December 11, 1995, 222 days after receiving the submission on May 3, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.
Device Classification
| Product Code | IKK — System, Isokinetic Testing And Evaluation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.1925 |
Manufacturer
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