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K Number
K022841
Device Name
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
Manufacturer
BIOMEDICAL LIFE SYSTEMS, INC.
Date Cleared
2002-11-19

(84 days)

Product Code
GZJ
Regulation Number
882.5890
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-taumatic acute pain problems.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not detail:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The letter focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).