Home / 510(k) Clearances / K841698

510(k) K841698

HEAT PACK by Maddak, Inc. — Product Code IMA

K841698 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "HEAT PACK". The FDA issued a decision of Substantially Equivalent on May 10, 1984. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1984
Date Received
April 23, 1984
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 Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)
  • K833090 — SENSORY ROLLER MASSAGER (October 14, 1983)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (March 24, 1995)
  • 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