510(k) K844388

ESCOTEK EST 220 INTERFERENCE THERAPY UNIT by Nor-Am Patient Care Products, Inc. — Product Code IPF

K844388 is an FDA 510(k) premarket notification submitted by Nor-Am Patient Care Products, Inc. for the device "ESCOTEK EST 220 INTERFERENCE THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Nor-Am Patient Care Products, Inc. has 6 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1985
Date Received
Nov 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type
510(k)

Source: FDA 510(k) database entry for K844388. Report a data issue: hello@regdatalab.com.