Ampcare, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000038602 FEI 3008273892
Ampcare, LLC is a medical device manufacturer based in the United States, with 7 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIa; FDA Class II) as of 13 Nov 2026.
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 5
- FDA GUDID 3
- FDA 510(k) 2
- Device classes
- EU Class I 4
- FDA Class II 2
- EU Class IIa 1
- Top EMDN categories
- Sites and related companies
- Obelis S.A. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000038602
- FDA FEI 3008273892
- DUNS 013052325
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Obelis S.A.BE
What Ampcare, LLC makes
Ampcare, LLC manufactures reusable cutaneous electrodes, lead wires, the Ampcare ESP Therapy System, Ampcare E Series Electrodes, Ampcare ES NMES, and the Ampcare Restorative Posture Device (RPD). These products are primarily related to neuromuscular electrical stimulation and posture correction.
The company's devices are regulated under Class I, Class II, and Class IIa classifications and are listed in both the EU EUDAMED and US FDA 510(k) registries. Ampcare, LLC is based in the United States.
Catalogue
Reusable Cutaneous Electrode Ref K121483
Regimes: 510(k) Registry: 510(k)Ampcare Esp Therapy System Ref K131222
Regimes: 510(k) Registry: 510(k)Ampcare E Series Electrodes Ref 50709LT
Regimes: CE MDR Registry: EUDAMEDGUDIDAmpcare ES NMES Ref 50701
Regimes: CE MDR Registry: EUDAMEDAmpcare Lead Wires Ref 50712
Regimes: CE MDR Registry: EUDAMEDAmpcare Restorative Posture Device (RPD) Ref 50707
Regimes: CE MDR Registry: EUDAMEDGUDIDAmpcare E Series Electrodes Ref 50709ST-1
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000038602
- FDA FEI number
- 3008273892
- DUNS number
- 013052325
- EUDAMED status
- Active
- EUDAMED registered name
- Ampcare, LLC
- EUDAMED abbreviated name
- Ampcare
- Registered address
- 1120, South Freeway, 76104, Fort Worth, United States
- Website
- www.swallowtherapy.com
- info@ampcarellc.com
- Phone
- +1 682 561 2444
- PRRC contact
- Leigh Campbell
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 24 Feb 2030
Intertek Medical Notified Body AB 2862 1 certificate
- 28620211194-01 Active
Quality management system EU MDR
- Issued
- 4 Aug 2026
- Expires
- 24 Feb 2030
- Reason
- Other
Frequently asked questions
How many devices does Ampcare, LLC have in the registry?
The registry currently lists 7 devices for Ampcare, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ampcare, LLC's devices?
Among its 7 most recently registered devices, Ampcare, LLC has devices listed in EUDAMED (5 devices), FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ampcare, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Ampcare, LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Ampcare, LLC?
EUDAMED lists 1 certificate for Ampcare, LLC (quality management system) under MDR. The most recent was issued on 4 Aug 2026.
What are the newest devices from Ampcare, LLC in the registry?
The most recently registered devices listed for Ampcare, LLC include REUSABLE CUTANEOUS ELECTRODE, AMPCARE ESP THERAPY SYSTEM, Ampcare E Series Electrodes and Ampcare ES NMES.