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510(k) K832803

STEAM PAK MOIST HEAT by Electro-Med Health Industries, Inc. — Product Code IMA

K832803 is an FDA 510(k) premarket notification submitted by Electro-Med Health Industries, Inc. for the device "STEAM PAK MOIST HEAT". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Electro-Med Health Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Heat, Moist
Device Class
Class I
Regulation Number
890.5730
Review Panel
PM
Submission Type

Other clearances by Electro-Med Health Industries, Inc.

  • K852077 — VERSA STIM 380, MUSCLE STIMULATOR (August 21, 1985)
  • K832371 — EGS MODEL 300 (October 6, 1983)
  • K832804 — SESAM TABLE (September 20, 1983)
  • K832370 — EGS MODEL 100-2 (September 16, 1983)
  • K802107 — EGS #300 BATTERY OPER. PORTA. MUSCLE STI (October 3, 1980)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (March 24, 1995)
  • K841698 — HEAT PACK (May 10, 1984)
  • K823622 — INSULATED THERMOELASTOMER MITT (December 30, 1982)
  • K803177 — MOIST HEAT PACK (December 31, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)
  • K790904 — STAO-HOTPACK (May 18, 1979)

FDA data resources