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510(k) K821046

COMPRES PORTABLE HEAT PADS by S.C. Johnson & Son, Inc. — Product Code IMD

K821046 is an FDA 510(k) premarket notification submitted by S.C. Johnson & Son, Inc. for the device "COMPRES PORTABLE HEAT PADS". The FDA issued a decision of Substantially Equivalent on April 29, 1982. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. S.C. Johnson & Son, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
April 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by S.C. Johnson & Son, Inc.

  • K964828 — VIREX II 128 GERMICIDAL CLEANER AND DEODORANT (December 19, 1996)
  • K964613 — VIREX II 256 GERMICIDAL CLEANER AND DEODORANT (December 13, 1996)
  • K964610 — TRIAD II DISINFECTANT CLEANER AND DEODORANT (December 13, 1996)
  • K964535 — VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT (December 13, 1996)

Other clearances for product code IMD

  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K163295 — Infant Transport Mattress Warmer with Disc (July 24, 2017)
  • K112547 — NEO NEST (March 6, 2012)
  • K082087 — EYEFEEL OPHTHALMIC WARMER (September 11, 2008)
  • K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (August 14, 2007)
  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)
  • K982652 — ALLEGIANCE PORTA-WARM MATTRESS (January 21, 1999)
  • K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (February 26, 1998)
  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K973770 — ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (November 13, 1997)

FDA data resources