MS-ONE, MODEL MS-1— 510(k) K994065

Substantially Equivalent

Home Wellness West

FDA 510(k) clearance K994065 for MS-ONE, MODEL MS-1, Substantially Equivalent on 2000-04-04. Applicant: Home Wellness West. Device class: 2.

Clearance details

Applicant: Home Wellness West
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1999-12-01
Decision date: 2000-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)2026-06-02
K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241433 — EVE Synergy (EVE-20M)2025-06-04

More clearances from Home Wellness West

K003258 — MS-ONE, MODEL MS-12001-01-12

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