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510(k) K150139

Rachel's Remedy by Rachel'S Remedies, LLC — Product Code IMA

K150139 is an FDA 510(k) premarket notification submitted by Rachel'S Remedies, LLC for the device "Rachel's Remedy". The FDA issued a decision of Substantially Equivalent on May 22, 2015. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
January 22, 2015
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 for product code IMA

  • 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)
  • K790904 — STAO-HOTPACK (May 18, 1979)

FDA data resources