OmniME 100MTS
OmniME 100MTS is a Class I device made by Accelerated Care Plus Corp, listed in FDA GUDID since 17 Aug 2023 (UDI-DI 00858703006320), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858703006320 | Date17 Aug 2023 | StatusListed |
Official records
- AccessGUDID record 00858703006320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- OmniME
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- 100MTS
- Primary DI / UDI-DI
- 00858703006320
- FDA product code
- ION
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class I
- Regulation number
- 890.5370
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ION (Exerciser, Non-Measuring).
- RHEUMATOID HAND GYM by Maddak, Inc.
- CANOPY, PARACHUTE, BK-8110 by Fred Sammons, Inc.
- THE VARIABLE LOAD KENETIC ENERGIZER by W.F. Pogue
- FINGER, HAND & WRIST EXERCISER by Robert W. Slack
- SPIN-A-PULL by Fred Sammons, Inc.
- OBJECTS PRECISION HANDLING TEST KIT by Metro. Hospital & Health Center
- Myo Munchee 1 by MYO MUNCHEE (OPERATIONS) PTY LTD
- KNEE WALKER by Maddak, Inc.
- EXERCISER, PASSIVE, NON MEASURING by Kaye Products, Inc.
- FLEXION-BRAKING KNEE-SHIN ASSEMBLY by Hosmer Dorrance Corp.