BIO-PROMPT(TM)— 510(k) K870568

Substantially Equivalent

Physical Health Devices, Inc.

FDA 510(k) clearance K870568 for BIO-PROMPT(TM), Substantially Equivalent on 1987-08-04. Applicant: Physical Health Devices, Inc.. Device class: 2.

Clearance details

Applicant: Physical Health Devices, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1987-02-10
Decision date: 1987-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCC

K233580 — A Breathing System (ABS)2024-08-01
K222101 — Prism2023-03-17
K180173 — Freespira2018-08-23
K163448 — GrindCare System2017-09-01
K151050 — Pacifier Activated Lullaby (PAL®)2015-12-22

More clearances from Physical Health Devices, Inc.

K890500 — ELT OR ERGONOMIC LIFT TRAINER1990-01-03

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