Powered Muscle Stimulator

FDA 510(k) K821511 · High Country Ent.

Substantially Equivalent

510(k) numberK821511

Submission

Device name
Powered Muscle Stimulator
Applicant
High Country Ent.
Mchenry, IL, US
Received
May 20, 1982
Decision date
August 16, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EPF – Hearing Aid, Group And Auditory Trainer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3320
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EPF

510(k)DeviceApplicantDecision
K133352Hypersound Audio System (HSS)EPF · Traditional Hypersound Health, Inc.02/12/2014SE
K982683Telex Select 1-40 with Adaptive CompressionEPF · Traditional Telex Communications, Inc.10/06/1998SE
K974658Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional Phonic Ear, Inc.02/25/1998SE
K974287FM Receiver - Auditory TrainerEPF · Traditional Phonic Ear, Inc.02/10/1998SE
K970687Williams Sound, Personal FM, Hearing HelperEPF · Traditional Williams Sound, LLC05/02/1997SE
K970665Williams Sound, Personal FM, Hearing HelperEPF · Traditional Williams Sound, LLC05/02/1997SE
K960567HF Mega EarEPF · Traditional Maxi-Aids, Inc.10/16/1996SE
K950730Group Auditory Trainer (Group Amplification System)EPF · Traditional Phonic Ear, Inc.06/30/1995SE
K941768Phonak Microvox Resonal FM SystemEPF · Traditional Phonak, Inc.06/24/1994SE
K940313Phonic EarEPF · Traditional Phonic Ear, Inc.03/22/1994SE

Questions and answers

When was Powered Muscle Stimulator cleared by the FDA?

Powered Muscle Stimulator (K821511) received a 510(k) decision of Substantially Equivalent on August 16, 1982, 88 days after the submission was received.

What is the product code of K821511?

The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.