Cleared Traditional

K900674 - CONSTI-SSAGE VIBRATOR/MASSAGE (FDA 510(k) Clearance)

Class I Physical Medicine device.

K900674 · Bio-Tech Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
17d
Days
Class 1
Risk

K900674 is an FDA 510(k) clearance for the CONSTI-SSAGE VIBRATOR/MASSAGE. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Bio-Tech Co. (Washington, US). The FDA issued a Cleared decision on March 2, 1990 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Tech Co. devices

Submission Details

510(k) Number K900674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date March 02, 1990
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 99
Devices cleared under the same product code (ISA) and FDA review panel - the closest regulatory comparables to K900674.
VMAT PRO
K243488 · Termosalud · Feb 2025
ShockPhysio Mobile (model SW3200 Basic)
K240358 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2024
BTL-094
K221865 · BTL Industries, Inc. · Apr 2023
Omnispec ED1000
K210166 · Medispec, Ltd. · Jan 2023
OW100S (model OW100S-US)
K213120 · Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · Oct 2022
DolorClast Radial
K220538 · E.M.S Electro Medical Systems S.A · Jul 2022