POWERED MUSCLE STIMULATOR— 510(k) K821511
Substantially EquivalentHigh Country Ent.
FDA 510(k) clearance K821511 for POWERED MUSCLE STIMULATOR, Substantially Equivalent on 1982-08-16. Applicant: High Country Ent.. Device class: 2.
Clearance details
- Applicant
- High Country Ent.
- Product code
- Code EPF
- Device class
- Class 2
- Regulation
- 21 CFR 874.3320
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code EPF
view all- K133352 — HYPERSOUND AUDIO SYSTEM (HSS)
- K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
- K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
- K974287 — FM RECEIVER - AUDITORY TRAINER
- K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
Data sourced from openFDA. This site is unofficial and independent of the FDA.