FAQ (FAQ 411)
Foreo, Inc. · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Las Vegas
- Advisory committee description
- Neurology
- Address 1
- 1525 E Pama Ln.
- Statement or summary
- Summary
- Product code
- NFO
- Zip code
- 89119
- Applicant
- Foreo, Inc.
- Decision date
- 2026-10-22
- Decision code
- SESE
- Country code
- US
- Device name
- FAQ (FAQ 411)
- Advisory committee
- NE
- Contact
- Feldstein Evan
- K number
- K261565
- State
- NV
- Date received
- 2026-05-11
- Review advisory committee
- NE
- Postal code
- 89119
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Medical specialty description
- Neurology
- Regulation number
- 882.5890
- Device class
- 2
- Registration number
- 3014980461, 3021177911, 3014737458, 3017133271, 3039394880, 3023339103, 3015286916, 3001224205, 3023356343, 3016076077, 3008929787, 3010027944, 3004786509, 3016413636, 9616877, 3013689783, 3008345424, 3005698910, 3043749884, 3007238544, 3018259873, 3033793026, 3006459199, 3012470925, 3038373471, 3037341611, 3045535064, 3004832480, 3004839404, 8040537, 3027645761, 3019577501, 3042261413, 3017953405, 3027651556, 3011883032, 3035374386, 3036720861, 3029740697, 3026264 +24 more
- FEI number
- 3014980461, 3021177911, 3014737458, 3017133271, 3039394880, 3023339103, 3015286916, 3001224205, 3023356343, 3016076077, 3008929787, 3010027944, 3004786509, 3016413636, 3013689783, 3008345424, 3005698910, 3043749884, 3007238544, 1000126561, 3018259873, 3033793026, 3006459199, 3012470925, 3038373471, 3037341611, 3045535064, 3002552319, 3004832480, 3004839404, 3027645761, 3019577501, 3042261413, 3017953405, 3027651556, 3011883032, 3035374386, 3036720861, 3029740697, 3006982887 +24 more