Escotek-Est 301A Ultra-Sonic Unit
by Nor-Am Patient Care Products, Inc.
510(k) K844386
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844386 | Date1 May 1985 | 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- Withdrawn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
- IMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5300
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Escotek-Est 301A Ultra-Sonic Unit is an ultrasonic diathermy device used for applying therapeutic deep heat. It is classified as a class 2 medical device under regulation number 890.5300.
This device received FDA 510(k) clearance under K844386. It is intended for use in the field of physical medicine.
Other devices from Nor-Am Patient Care Products, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the primary clinical application of the Escotek-Est 301A?
The Escotek-Est 301A is an ultrasonic diathermy device specifically intended for use in physical medicine to apply therapeutic deep heat to patients.
What is the regulatory classification of this device?
This device is classified as a class 2 medical device under regulation number 890.5300, which pertains to ultrasonic diathermy equipment used for therapeutic purposes.
Has this device received regulatory clearance?
Yes, the Escotek-Est 301A Ultra-Sonic Unit received FDA 510(k) clearance under K844386, confirming it was found to be substantially equivalent to existing devices.