510(k) K810222

LIMB ORHTOSIS by Medical Design & Manufacturing Corp. — Product Code ITQ

K810222 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "LIMB ORHTOSIS". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code ITQ (Joint, Knee, External Brace), a Class I device regulated under 21 CFR 890.3475. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
January 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type