HEAD HALTER— 510(k) K830245

Substantially Equivalent

Warm & Form, Orthopedic Materials

FDA 510(k) clearance K830245 for HEAD HALTER, Substantially Equivalent on 1983-03-09. Applicant: Warm & Form, Orthopedic Materials. Device class: 1.

Clearance details

Applicant: Warm & Form, Orthopedic Materials
Product code: Code ILZ
Device class: Class 1
Regulation: 21 CFR 890.5925
Advisory panel: Physical Medicine
Date received: 1983-01-25
Decision date: 1983-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILZ

K921711 — FLEXION DISTRATION SUPPORT1992-07-13
K895382 — VIBRA-TRAC TRACTION TABLE1989-10-16
K884340 — AMX-110, AMX-II AND AMX-III1989-01-24
K852398 — VECTOR BAR SUSPENSION/TRACTION UNIT1985-08-12
K844490 — TRACTION ACCESSORIES1985-02-21

More clearances from Warm & Form, Orthopedic Materials

K830244 — TRACTION ACCESSORIES1983-03-09
K830243 — ABDUCTION PILLOW1983-03-08
K830246 — CAST SHOE, CAST BOOT1983-02-18
K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL)1982-12-30
K823659 — PELVIC TRACTION BELT1982-12-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.