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K Number
K032954
Device Name
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
Manufacturer
DANMETER A/S
Date Cleared
2004-08-09

(322 days)

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

ELPHA // 500, ELPHA // 1000: This Danmeter device is designed for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.

ELPHA // 2000: This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

ELPHA II 3000: This Danmeter device is designed for:

  • Symptomatic relief and management of chronic (long-term), intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
  • Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for several models of the ELPHA device. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. The "Indications for Use" section describes the intended medical purposes of the different ELPHA models, but it does not specify performance metrics, study designs, or analytical results.

Therefore, I cannot fulfill your request for the following information based on the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method: Not present.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not present.
  6. Standalone performance information: Not present.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

§ 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).