Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOF-BAND HIGH STRETCH BANDAGES

K-Number: K810137 · 1981-02-17

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1981-02-17
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOF-BAND HIGH STRETCH BANDAGES is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1981-02-17 under 510(k) number K810137. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF-BAND HIGH STRETCH BANDAGES?

SOF-BAND HIGH STRETCH BANDAGES is a medical device that received FDA 510(k) clearance on 1981-02-17. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K810137.

When did SOF-BAND HIGH STRETCH BANDAGES receive FDA 510(k) clearance?

SOF-BAND HIGH STRETCH BANDAGES received FDA 510(k) clearance on 1981-02-17, under 510(k) number K810137.

Who is the listed applicant for SOF-BAND HIGH STRETCH BANDAGES?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOF-BAND HIGH STRETCH BANDAGES?

The FDA product code for SOF-BAND HIGH STRETCH BANDAGES is FQM.

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 Johnson & Johnson Professionals, Inc. 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.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

View all 206 devices →

Related Devices (Code: FQM)

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.

K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore BarashK013244COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBEMed Gen, Inc.K952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.K872868ASPEN ESMARK BANDAGEAspen Laboratories, Inc.K840107TUBE-BANDAGE FOR HUMAN DIGITS 200Zens Health Care Products

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.

↑