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510(k) K813533

ELECTRIC MUSCLE STIMULATOR by Myo-Tronics Research, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1982
Date Received
December 17, 1981
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

Other clearances by Myo-Tronics Research, Inc.

  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K842224 — BNS 40 (November 19, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K831364 — TESTCORP RA (May 27, 1983)
  • K830034 — MODEL EM-2 BIOELECTRIC PROCESSOR (February 9, 1983)
  • K810528 — MODEL EM-IR (March 31, 1981)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

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