510(k) clearances

BEAR 2 Body

Foreo, Inc. · Neurology

K232242Substantially EquivalentTraditionalNFO
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
Statement
Product code
NFO
Zip code
89119
Applicant
Foreo, Inc.
Decision date
2024-05-13
Decision code
SESE
Country code
US
Device name
BEAR 2 Body
Advisory committee
NE
Contact
Evan Feldstein
K number
K232242
State
NV
Date received
2023-07-28
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.