Home / 510(k) Clearances / K831899

510(k) K831899

ENSWELL by Dr. Micheal A. Sabia — Product Code IME

K831899 is an FDA 510(k) premarket notification submitted by Dr. Micheal A. Sabia for the device "ENSWELL". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Dr. Micheal A. Sabia has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
June 14, 1983
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 by Dr. Micheal A. Sabia

  • K831898 — SCOLIMETER (July 19, 1983)

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)
  • 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