NEO-WAVE SYSTEM— 510(k) K810543

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K810543 for NEO-WAVE SYSTEM, Substantially Equivalent on 1981-03-06. Applicant: Gaymar Industries, Inc.. Device class: 2.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code INX
Device class: Class 2
Regulation: 21 CFR 890.5160
Advisory panel: Physical Medicine
Date received: 1981-02-27
Decision date: 1981-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code INX

K972176 — HOME CARE BEAD BED1998-01-16
K964223 — CLINITRON RITE-HITE1997-05-28
K943385 — CLINITRON ELEXIS1995-02-27
K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY1995-02-07
K931168 — X-20 AIR SUPPORT BED1994-02-17

More clearances from Gaymar Industries, Inc.

K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA79002011-01-20
K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2008-05-08
K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM1997-04-30
K963067 — SOF. PRESS EPC 51 SYSTEM1997-01-28
K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL2121996-08-09

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