ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT— 510(k) K910149

Name: FDA 510(k) clearance K910149
Creator: U.S. Food and Drug Administration
Published: 1991-01-18

Substantially Equivalent

Dyna Flex, Intl.

FDA 510(k) clearance K910149 for ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT, Substantially Equivalent on 1991-01-18. Applicant: Dyna Flex, Intl.. Device class: 1.

Clearance details

Applicant: Dyna Flex, Intl.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1991-01-14
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clinton, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dyna Flex, Intl.

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K910150 — ROMFLEX REHAB EQUIP EXTREMITIES UNIT1991-01-23
K910151 — ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT1991-01-18
K905299 — ROMFLEX REHABILITATION EQUIPMENT1990-12-31

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