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K Number
K980958
Device Name
HAKOMED ELECDT/VACUPULLS
Manufacturer
ALIVE, INC.
Date Cleared
1998-05-11

(56 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long-term) pain; as an adjunctive treatment in the management of post-surgical pain problems; relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing local blood circulation; muscle re-education; immediate postsurgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of motion. To stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Hakomed Elecdt/Vacupulls" device. It is a regulatory approval letter and does not contain information about acceptance criteria or specific study details proving a device meets them.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976"

This means the device was approved based on its substantial equivalence to a predicate device already on the market, rather than a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information for the Hakomed Elecdt/Vacupulls device based on the provided text. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
  3. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size.
  4. Information on a standalone performance study.
  5. Details on the type of ground truth used.
  6. Sample size for a training set or how ground truth was established for it.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).