MASSAGING HELMET C.F. HANSEN DESIGN— 510(k) K940582

Name: FDA 510(k) clearance K940582
Creator: U.S. Food and Drug Administration
Published: 1995-01-30

Substantially Equivalent for Some Indications

Philco Ushuaia

FDA 510(k) clearance K940582 for MASSAGING HELMET C.F. HANSEN DESIGN, Substantially Equivalent for Some Indications on 1995-01-30. Applicant: Philco Ushuaia. Device class: 1.

Clearance details

Applicant: Philco Ushuaia
Product code: Code IRO
Device class: Class 1
Regulation: 21 CFR 890.5975
Advisory panel: Physical Medicine
Date received: 1994-02-08
Decision date: 1995-01-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRO

view all

K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER1996-02-08
K955250 — QI GONG MASSAGER1996-02-08
K954203 — MASSAGER THERAPUTIC, ELECTRIC1995-12-11
K952916 — SHIATSU MASTER MASSAGER CUSHION1995-08-28
K951414 — CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR1995-08-11

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