FDA 510(k)

EXERCISER, PASSIVE, NON MEASURING

K-Number: K830560 · 1983-03-09

Decision Date1983-03-09

Product CodeION

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

EXERCISER, PASSIVE, NON MEASURING is the device name listed in this FDA 510(k) record. The listed applicant is Kaye Products, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830560. The device is classified under product code ION. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXERCISER, PASSIVE, NON MEASURING?

EXERCISER, PASSIVE, NON MEASURING is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Kaye Products, Inc.. The 510(k) number is K830560.

When did EXERCISER, PASSIVE, NON MEASURING receive FDA 510(k) clearance?

EXERCISER, PASSIVE, NON MEASURING received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830560.

Who is the listed applicant for EXERCISER, PASSIVE, NON MEASURING?

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

What is the FDA product code for EXERCISER, PASSIVE, NON MEASURING?

The FDA product code for EXERCISER, PASSIVE, NON MEASURING is ION.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kaye Products, Inc. as applicant

K924848KAYE SCOOT-ABOUT, MODEL SB1 K923095KAYE MODEL KIAO PELVIC/THIGH STABILIZER K922061CHAIR, ADJUSTABLE, MECHANICAL K885330WHEELCHAIR, MECHANICAL K833869CHILD'S WALKER K830466BARS, PARALLEL, EXERCISE

View all 12 devices →

Related Devices (Code: ION)

K120783ABLE-XIm-Able, Ltd.K885343STANDEXAlt, Inc.K851065GRAVITY KING (DEEMED SE 87/09/18)Unique Functional Products K840551MOBILIZERLossing Orthopedic, Inc.K833870KNEE WALKERMaddak, Inc.K833249FITNESSFitness Equipment Co., Inc.

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.