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FDA 510(k)

ROBO

K-Number: K942508 · 1994-11-07

ApplicantPermobil AB
Decision Date1994-11-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

ROBO is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K942508. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ROBO?

ROBO is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Permobil AB. The 510(k) number is K942508.

When did ROBO receive FDA 510(k) clearance?

ROBO received FDA 510(k) clearance on 1994-11-07, under 510(k) number K942508.

Who is the listed applicant for ROBO?

The FDA 510(k) record lists Permobil AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROBO?

The FDA product code for ROBO is INI.

Related PubMed Literature

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.

PMID: 42618680Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005-2026.Journal of robotic surgery ()PMID: 36976820Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.PloS one ()PMID: 36074993Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.Global spine journal ()PMID: 35349537Prospective Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscle: A 510(k) Approval Study with U.S. Food and Drug Administration Investigational Device Exemption.Plastic and reconstructive surgery ()

Other records listing Permobil AB 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.

K190682Explorer MiniK191874F5 Corpus VSK123290M300 & M400K103477PERMOBIL M300 / M400K081964K450 POWERED WHEELCHAIRK071650C350 POWERED WHEELCHAIR

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Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

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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