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510(k) K820901

COLD ROLL by North Bank Labs, Inc. — Product Code IME

K820901 is an FDA 510(k) premarket notification submitted by North Bank Labs, Inc. for the device "COLD ROLL". The FDA issued a decision of Substantially Equivalent on April 15, 1982. 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
April 15, 1982
Date Received
March 31, 1982
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)
  • K863654 — RE-HEATER, HOT PACK (October 23, 1986)
  • 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)

FDA data resources