NICE PACK— 510(k) K832193

Clearance details

Applicant

Universal Medical Instrument Corp.

Product code

Code IME

Device class

Class 1

Regulation

21 CFR 890.5700

Advisory panel

Physical Medicine

Date received

1983-07-08

Decision date

1983-08-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K923627 — COLD PACK1993-04-14
• K915876 — HOTPAD1993-02-12
• K921446 — HOT OR COLD PACK (THERMIPAQ)1992-07-13
• K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS1991-01-22
• K882413 — SUBOCCIPITAL ICE PILLOW1988-11-30

• K962180 — CATH SEAL1996-11-07
• K935077 — CATH-SEAL1994-06-07
• K897128 — UMI BRAIDED CATHETER CONNECTOR1990-03-01
• K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE1988-07-26
• K863178 — UMI STEERABLE TORQUE GUIDE WIRE1986-09-19

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →