Applicator 9401
Applicator 9401 is a Class II device made by Mettler Electronics Corp., cleared under FDA 510(k) K071137 on 1 Aug 2007 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 00816864020661), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816864020661 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071137 | Date1 Aug 2007 | StatusActive |
Official records
- AccessGUDID record 00816864020661
- FDA 510(k) database K071137
Across registries
- FDA 510(k) K071137 decided 1 Aug 2007 Active
- FDA GUDID UDI-DI 00816864020661 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K071137
- Listed FDA GUDID 00816864020661
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Physical therapy ultrasound system applicator, hand-held
- Model / Ref / Catalog
- 9401
- Primary DI / UDI-DI
- 00816864020661
- 510(k) Number
- FDA product code
- LIH, GZJ, IMG
- GMDN term
- Physical therapy ultrasound system applicator, hand-held
- Device class
- Class II
- Regulation number
- 882.5890, 890.5860
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LIH (INTERFERENTIAL CURRENT THERAPY).
- ETD4000 by Therasigma, LLC
- ENDODYNE DUAL by Elmed, Inc.
- IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 by Theratech, Inc.
- ISOTRON III by Excel Tech., Ltd.
- VECTOR SEIGE 2023645 AC POWERED STIMU- by Metronex Engineering
- IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND by Theratech, Inc.
- MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 by Nisha Communication Industries
- POWERED MUSCLE STIMULATOR by M.S.P., Ltd.
- DYNATRON 400 by Dynatronics Corp.
- MEDI-STIM by Mid-Canada Medical