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510(k) K863654

RE-HEATER, HOT PACK by K & L Ent. — Product Code IME

K863654 is an FDA 510(k) premarket notification submitted by K & L Ent. for the device "RE-HEATER, HOT PACK". The FDA issued a decision of Substantially Equivalent on October 23, 1986. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1986
Date Received
September 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Reusable
Device Class
Class I
Regulation Number
890.5700
Review Panel
PM
Submission Type

Other clearances for product code IME

  • K923627 — COLD PACK (April 14, 1993)
  • K915876 — HOTPAD (February 12, 1993)
  • K921446 — HOT OR COLD PACK (THERMIPAQ) (July 13, 1992)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)
  • K882413 — SUBOCCIPITAL ICE PILLOW (November 30, 1988)
  • K832193 — NICE PACK (August 31, 1983)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)
  • K823649 — THERMOELASTOMER HOT/COLD COMPRESS BK7186 (January 21, 1983)

FDA data resources