Identity
- Trade Name
- REPRO-MED - THD FDA PMA
- Generic Name
- DEVICE, TESTICULAR HYPOTHERMIA FDA PMA
Identifiers
- PMA Number
- P820034 FDA PMA
- FDA Product Code
- LOA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
REPRO-MED - THD is a device classified as a testicular hypothermia device. It is designed to reduce testicular temperature for therapeutic purposes.
The device is supplied as a reusable system intended for use in clinical settings. It has been authorized via FDA Premarket Approval (PMA) with decision date December 26, 1984, and is manufactured by Repro-Med Systems, Inc. in New York.
Frequently asked questions
What is the generic name of the REPRO-MED - THD device?
The generic name of the REPRO-MED - THD device is Device, Testicular Hypothermia, as specified in the device data under the generic_name field.
When did the REPRO-MED - THD receive FDA approval?
The REPRO-MED - THD received FDA approval on December 26, 1984, as indicated by the decision_date field in the device data.
What is the PMA number for the REPRO-MED - THD device?
The PMA number for the REPRO-MED - THD device is P820034, which is explicitly listed in the specifications under pma_number.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P820034 | Class III | Active |
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Manufacturer
- Manufacturer
- Repro Med Systems, Inc.
- FDA Applicant
- Repro-Med Systems, Inc.
Sources (1)
- FDA PMA P820034 24 fields · synced Sep 18, 2026