Handi-Foam
by Medtec LLC
510(k) K935021
Handi-Foam is a Class II device made by Medtec LLC, cleared under FDA 510(k) K935021 on 7 Apr 1994, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935021 | Date7 Apr 1994 | StatusActive |
Official records
- FDA 510(k) database K935021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Medtec, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- NA TANDEM T10016 by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
- Klarity Medical R550-TL by Klarity Medical Products, LLC
- DART-12 by Direx Systems Corp.
- LIAC HWL by Sit Sordina Iort Technologies Spa
- KLARITY MEDICAL RE-7E3 by Klarity Medical Products, LLC
- Pillow Short Neck E - Low Density Transparent P10107-228 by IT-V Medizintechnik GmbH
- STELLAR FIDUCIAL MARKER, MODEL GFMIA by Stellar Medical, LLC
- PATIENT POSITIONING ACCESSORIES by Perkins Mfg. Co.
- ISOCENTRIC BEAM CHECKER by Mick Radio-Nuclear Instruments, Inc.
- PUMA MODEL VERSION 1.0 by Prowess, Inc.