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FDA 510(k)

ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT

K-Number: K910151 · 1991-01-18

ApplicantDyna Flex, Intl.
Decision Date1991-01-18
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex, Intl.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K910151. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT?

ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Dyna Flex, Intl.. The 510(k) number is K910151.

When did ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT receive FDA 510(k) clearance?

ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT received FDA 510(k) clearance on 1991-01-18, under 510(k) number K910151.

Who is the listed applicant for ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT?

The FDA 510(k) record lists Dyna Flex, Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT?

The FDA product code for ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT is BXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dyna Flex, Intl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910150ROMFLEX REHAB EQUIP EXTREMITIES UNITK910149ROMFLEX REHAB EQUIP LATERAL FLEXION UNITK905299ROMFLEX REHABILITATION EQUIPMENT

Related Devices (Code: BXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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