Thumper Model P-1000
510(k) K880597
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880597 | Date29 Mar 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BYI
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5665
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Thumper Model P-1000 is a powered-electric percussor device, classified under FDA regulation 868.5665. It is designed to deliver mechanical percussion therapy, typically used to assist in the mobilization of secretions in respiratory care and to enhance lung expansion during anesthesia or critical care procedures.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as operating rooms or intensive care units. It operates under electrical power and requires proper maintenance and calibration to ensure safe and effective performance. The Thumper Model P-1000 holds a 510(k) clearance from the FDA, classified as a Class II device, and was determined to be substantially equivalent to a legally marketed predicate device in 1988.
Other devices from Micro Tek Engineering
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is the Thumper Model P-1000 primarily used for?
The Thumper Model P-1000 is designed to deliver mechanical percussion therapy, which helps mobilize respiratory secretions in patients. It is commonly used in anesthesia or critical care settings to assist with lung expansion and secretion clearance, improving patient outcomes during procedures or intensive care.
Is the Thumper Model P-1000 intended for single-use or reusable applications?
The Thumper Model P-1000 is explicitly described as a reusable medical instrument. Since it operates in clinical environments like operating rooms or intensive care units, proper maintenance and calibration are required to ensure safe and effective performance over repeated uses.
What regulatory pathway was followed for FDA clearance of the Thumper Model P-1000?
The Thumper Model P-1000 received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device. It was determined to be substantially equivalent to a legally marketed predicate device in 1988, with the decision based on an advisory committee review (AN—Anesthesiology).
How is the Thumper Model P-1000 powered, and what maintenance is required?
The Thumper Model P-1000 operates using electrical power. Since it is a reusable device, it requires proper maintenance and calibration to ensure safe and effective performance. Regular upkeep is essential, particularly in clinical settings where reliability is critical.
Are there different models or sizes available for the Thumper Model P-1000?
The provided data does not specify multiple models or sizes for the Thumper Model P-1000. However, the device is listed under OpenFDA registration numbers, which may indicate variations in manufacturing lots or minor configurations. For exact sizing or model variations, consult the manufacturer’s documentation or contact Micro Tek Engineering directly.