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510(k) K790904

STAO-HOTPACK by Staodynamics, Inc. — Product Code IMA

K790904 is an FDA 510(k) premarket notification submitted by Staodynamics, Inc. for the device "STAO-HOTPACK". The FDA issued a decision of Substantially Equivalent on May 18, 1979. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Staodynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1979
Date Received
May 11, 1979
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 Staodynamics, Inc.

  • K852298 — TENS-AID STERILE ELECTRODES FOR POST-OP TENS (June 24, 1985)
  • K843964 — TENS-AID PREMIUM ELECTRODES (February 25, 1985)
  • K832988 — STAODYN EMS/PLUS (November 22, 1983)
  • K813283 — 10D (TENS DEVICE) (February 10, 1982)
  • K813098 — TENS DEVICE (November 20, 1981)
  • K811345 — INSIGHT (July 10, 1981)
  • K792529 — POINT LOCATOR STIMULATOR (February 26, 1980)
  • K792501 — PLS MINI (February 26, 1980)
  • K800068 — ELECTRICAL MUSCLE STIMULATOR (EMS) (February 5, 1980)
  • K792502 — TENS 4100 (December 18, 1979)

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)
  • K832803 — STEAM PAK MOIST HEAT (September 20, 1983)
  • K823622 — INSULATED THERMOELASTOMER MITT (December 30, 1982)
  • K803177 — MOIST HEAT PACK (December 31, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)

FDA data resources